case study on fibroid uterus

Case report

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• Published: 13 July 2021

Massive uterine fibroid: a diagnostic dilemma: a case report and review of the literature

• Wiesener Viva 1 ,
• Dhanawat Juhi   ORCID: orcid.org/0000-0002-4273-1376 1 , 2 ,
• Andresen Kristin 1 ,
• Mathiak Micaela 3 ,
• Both Marcus 4 ,
• Alkatout Ibrahim 1 &
• Bauerschlag Dirk 1  

Journal of Medical Case Reports volume  15 , Article number:  344 ( 2021 ) Cite this article

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Fibroids of the uterus are the most common benign pelvic tumors in women worldwide. Their diagnosis is usually not missed because of the widespread and well-established use of ultrasound in gynecological clinics. Hence, the development of an unusually large myoma is a rare event, particularly in first-world countries such as Germany. It is even more uncommon that a myoma is misdiagnosed as a dietary failure.

Case presentation

Herein, we report the case of a Caucasian woman with a giant fibroid that reached a size of over 50 cm, growing slowly over the past 15 years, and was misdiagnosed as abdominal fat due to weight gain. We aim to discuss the factors that lead to the growth of such a huge tumoral mass, including misdiagnosis and treatment, and the psychological impact. Through this case, we intend to increase the awareness among general physicians and gynecologists. Although menstrual disorders incorporate several pathologies, adequate assessment remains the primary responsibility of health care providers. A literature review revealed approximately 60 cases of giant uterine fibroids.

The use of clinical and diagnostic devices, especially ultrasound, in this case, is indispensable. In conclusion, the growth of a giant fibroid can have disastrous effects on a woman’s health, including surgical trauma and psychological issues.

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Introduction

Leiomyomas or fibroids are the most common benign pelvic tumors in females that grow monoclonally from the smooth muscle cells of the uterus. Such tumors occur in nearly half of women over the age of 35 years, with increased prevalence during the reproductive phase due to hormone-stimulated growth [ 1 ]. At 50 years of age, 80% of African and almost 70% of Caucasian women have fibroids [ 2 ]. As the underlying pathogenesis of the development of these tumors remains unclear, several risk factors, such as positive family history, genetic alterations, and lifestyle factors (smoking, obesity, dyslipidemia, nutrition, exercise, and medical contraception), have been identified. Treatment of these lifestyle-associated risk factors with vitamin D supplementation, statin use, and dietary modification appears to be protective, along with parity [ 1 , 3 ]. Myomas may occur as a single lesion or as multiple lesions as reported in two-third of the cases, with variation in size from microscopic to large macroscopic extent [ 1 , 4 ]. As the majority of women with myomas remain asymptomatic [ 2 ], the number of undiagnosed uterine fibroids is high. Symptomatic women most likely suffer from abnormal uterine bleeding (meno- or metrorrhagia and polymenorrhea) as well as dysmenorrhea. Other frequent symptoms include dyspareunia or chronic acyclic pelvic pain [ 3 ]. Fibroids affect fertility [ 5 ] and can have a severe psychological impact on a woman’s life [ 3 ]. With continued growth, myomas can cause compression-related symptoms, such as dyspnea, frequent urination, or bowel complaints. The growth rate of myomas varies intra- and interindividually, thereby regressing or gradually increasing in size until the climacteric period is possible [ 1 ]. The identification of rapidly progressing growing fibroids requires close observational ultrasound examinations. Extremely large myomas can involve serious complications such as respiratory failure due to diaphragmatic compression [ 6 ] or incarcerated abdominal wall hernia [ 7 ].

In Germany, universal access to healthcare services is guaranteed by law [ 8 ]. The German ambulatory care sector is densely structured with accessibility of general physicians in less than 30 minutes in more than 90% of all cases [ 9 ]. Utilization of gynecological services in Germany usually begins between the ages of 15 and 16 years [ 10 ] and continues at age 20 with annual visits for prevention of cervical carcinoma [ 11 ], followed by recurrent examinations for breast cancer prevention [ 12 ]. The self-reported prevalence of myomas is high in German women (8.0%), with a mean age of 33.5 years at diagnosis. After the USA, Germany has the second-highest hysterectomy rate among women with uterine fibroids (29.1% versus 21.8%) [ 3 ]. Although diagnosis of a giant myoma is difficult with several possible differential diagnoses, the majority of uterine myomas are confidently diagnosed in the (pre-)clinical routine [ 1 ]. Herein, we present a rare case of a German woman whose uterine tumor was misdiagnosed and remained untreated for the past 15 years, growing into a giant fibroid (16.4 kg) with a size over 50 cm.

A nulligravid, 46-year-old German woman presented to the gynecology clinic because of abnormal uterine bleeding and a slowly increasing abdominal extent in the past 15 years. She had no bowel or bladder complaints. The patient reported two episodes of polymenorrhea and menorrhagia in the past years. Due to the patient’s general fear of physicians and absence of frequent symptoms, she consulted her gynecologist and general physician sporadically. The gynecologist did not use ultrasound to clarify the uterine pathology. The general physician attributed her progressive abdominal extent to weight gain and advised dietary change and physical exercise as management. Both primary health care providers did not perform a thorough physical examination, including imaging methods, leaving the fibroid undiagnosed and untreated.

In our clinic, a preliminary physical examination was performed, which indicated good general condition and no evidence of pallor or pedal edema. The patient’s preoperative body mass index (BMI) was 32.1 kg/m 2 . Her abdomen was enormously enlarged and pendulous with flank fullness on both sides. An irregular mass arose from the pelvis up to the xiphisternum and was not discernible owing to abdominal wall obesity. There were no hernias or abdominal varices. Renal angle fullness was not observed. Because of the patient’s anxiety, a vaginal examination could not be performed. Transabdominal ultrasound showed a huge intraabdominal mass. The right kidney showed impaired cirrhosis, while the left kidney showed compensatory enlargement. A small amount of ascites was observed. An urgent computed tomography (CT) scan was performed revealing a large tumor that occupied the abdominopelvic cavity completely. On the CT scan, the mass measured 32 × 27 × 34 cm (intralesion diameter) and could not be visibly separated from the uterine cavity, bladder, or liver (Fig. 1 ). The tissue of origin and extent of tumor invasion remained unclear. The mass appeared heterogeneous, containing cystic and necrotic areas along with solid components. It compressed the intestines, right kidney, and both ureters. The spleen was mildly enlarged. The hepatorenal recess (Morison’s pouch) showed minimal ascites. No lymph nodes were observed. Due to the slow growth of the tumor, few ascites, and negative lymph nodes, malignancy was highly unlikely.

CT reveals extensive abdominal enlargement in the scout view ( a ). Sagittal CT reconstruction depicts a giant tumor in contact with the liver (black arrow, b ) and with the urinary bladder (black arrowhead, b ). The mass contains necrotic components (white asterisk, c ), as well as small calcifications (black asterisk, d ). The preoperative situs shows compression of the right kidney (white arrow, c ) and ascites adjacent to the tumor (white arrowhead, d )

A midline longitudinal incision was made from the xiphisternum to the pubic symphysis, and the abdomen was opened. A large mass arising from the uterus up to the xiphisternum, firm in consistency with enlarged superficial veins, was seen. The mass extended laterally to both flanks and occupied the right and left hypochondrium. No adhesions to the intestinal organs were observed. The bilateral ovaries were enlarged to twice the normal size, with ovarian artery pulsation seen on both sides. Additionally, the bilateral fallopian tube round ligaments were thickened (Fig. 2 a and b). Due to the in situ findings, a total abdominal hysterectomy en bloc with bilateral salpingectomy was performed, and both ovaries were left intraabdominally. Postoperatively, bilateral ureteric peristalsis was confirmed. Intraoperative blood loss was 400 ml. The patient’s postoperative clinical course within 5 days of hospital stay remained complication-free with quick recovery. She was discharged after 5 days of surgery and had good overall health.

The tumor shows a dilated fallopian tube and an enlarged ovary ( a ). The fibroids appear macroscopically inhomogeneous with enlarged superficial vessels ( b )

Pathology confirmed a myomatous uterus measuring 52 × 37 ×  3 cm and weighing 16.4 kg. The tumor consisted of two separate myomas with diameters of more than 30 cm. Macroscopically, the shape was irregular, with overall consistency being firm with few soft areas. The tumor was pinkish-red in color, similar to (smooth) muscle cells. On the surface, enlarged aberrant blood vessels were observed. The cervix appeared normal, as well as bilateral fallopian tubes, although they were enlarged. For further histopathological examination, a cut section (total of 38 blocks) was performed, and tissue sections were stained with hematoxylin and eosin and examined under a light microscope. The cut sections revealed a heterogeneous phenotype with predominant white whirling structures. Microscopically, the tumoral mass consisted of smooth muscle cells and collagen bundles. Few areas had nuclear polyploidy, blood vessels, and enlarged glands with some superficial hemorrhagic areas. There was no evidence of malignancy.

Although uterine leiomyomas are frequent in women, fibroids > 50 cm in size, similar to the present case, with a weight of 11.6 kg (25 lb) and more being defined as giant , are exceedingly rare. The potential for benign tumors to outgrow quietly without causing specific symptoms is reasonable because of the large volume of the abdominal cavity, flexibility, and slow growth rate of the tumor [ 2 ]. The largest myoma ever reported weighed 63.3 kg and was discovered on autopsy [ 13 ]. Online search using the PubMed database showed approximately 60 cases of giant uterine myomas in the past 50 years worldwide [ 14 ]. Table 1 summarizes the global cases of giant uterine fibroids in the past 20 years.

Preoperative imaging studies are useful to define the extent of the tumor and to assess the likelihood of malignancy in cases of expansive or infiltrative growth. Ultrasonography is the preferred technique for the initial evaluation of gynecologic pathology because of its ubiquitous availability, noninvasiveness, and convenient cost–benefit ratio [ 15 ]. In the present case, preclinical ultrasound imaging would have been absolutely appropriate with regard to diagnosis, surveillance, and prevention of myoma-associated complications. As fibroids continue to grow, they outgrow their blood supply. Therefore, giant myomas often undergo degenerative changes, and dystrophic calcification can complicate the diagnosis [ 16 ]. Although a CT scan may not be the preferred method, many myomas are detected incidentally by CT imaging [ 15 ]. The widespread clinical use of a CT scan lies in its availability, time saving, and comfortable use. Lastly, magnetic resonance imaging (MRI) is recommended to define and measure uterine pathology confidently. As our patient was claustrophobic, MRI was not suitable for her. This imaging method is predominantly utilized in first-world countries in maximum-care hospitals because of its high cost. The atypical appearance of fibroids substantially limits the preoperative informative value of all techniques [ 15 , 16 ]. Hence, the underestimation of the presented fibroid was due to its histologic composition that did not allow precise separation from the intestinal organs.

Uterine leiomyomas have been misdiagnosed as adenomyosis, hematometra, uterine sarcoma, ovarian masses, and pregnancy [ 15 , 17 , 18 ]. Other common non-gynecological differential diagnoses include gastrointestinal tumors or inflammation [ 19 ]. Fibroids often occur with endometriosis and adenomyosis, with an overlap of symptoms [ 20 ], which significantly reduces diagnostic confidence. The position of the fibroid in relation to the uterus affects the patient’s symptoms and diagnostic specificity. Myomas occur within the muscular layer (70% of all cases; intramural), on the outside (20% of all cases; subserosal), or the inside (10% of all cases; submucosal) of the uterine cavity where they possibly have a connective stalk (pedunculation). Pedunculated subserosal myomas can be acutely symptomatic owing to torsion with obstruction of blood vessels, which requires immediate surgery. They often mimic the ovarian pathology. Another differential diagnosis is uterine cancer, with carcinomas being the most frequent and sarcomas and carcinosarcomas occurring rarely [ 2 ]. Malignant transformation of a leiomyoma to a leiomyosarcoma occurs in 0.2% of all cases [ 16 ]. It should be stressed that no imaging method can rule out malignancy so far, leaving the diagnosis of a giant uterine fibroid a challenge. Fibroids of an enormous extent cannot be treated with the most widely used minimally invasive surgery techniques: hysteroscopic myomectomy, vaginal hysterectomy, or total laparoscopic hysterectomy (TLH)/laparoscopic-assisted supracervical hysterectomy (LASH). Similar to the present case, the majority of giant fibroids are removed during total abdominal hysterectomy with additional bilateral salpingo-oophorectomy, depending on the patient’s age and affection of both adnexa. Intraoperatively, severe complications such as hemodynamic instability can occur because of extensive blood loss [ 2 , 21 ]. With regard to the amount of surgery, the general morbidity and mortality in patients who receive a laparotomy is remarkably higher. Postoperative complications include venous thrombosis and acute renal failure [ 22 ]. Generally, giant myomas are fatal for the patient; therefore, such patients have to be treated similarly to older multimorbid patients [ 2 ], with death being a possible outcome [ 23 ].

The prevention of giant fibroid development with close surveillance and early surgical therapy for women with progressive myomas is the clinical gold standard. In Germany, uterine fibroids indicate surgical hysterectomy in 60.7% of all cases [ 20 ]. This underlies the fact that uterine tumors are a relevant reason for hospitalization in women. The development of such a giant myoma in the present case is surprising despite the easy accessibility to professional care and high educational standard of the population in Germany. According to Stentzel et al. , the utilization of professional care depends on several personal factors rather than travel time. In particular, a high socioeconomic status was positively correlated with visits to gynecological care [ 9 ]. Data from the cross-sectional German Health Survey (GEDA) indicate that low social status correlates with less participation in medical check-ups [ 24 ]. This strengthens the role of education in the requirement of self-consciousness and awareness of health checks.

Given the patient’s unemployment for the last 3 years and her modest family background, her low socioeconomic status could have contributed to her worsening condition. Additionally, her general anxiety and previously diagnosed depressive state of mind could have led to the rejection of professional care. The misdiagnosis by her previous doctors could be explained by her lack of complaint regarding irregular menstruation. Women with fibroids of this size are expected to most likely suffer from menstrual disorders [ 1 ], but the patient presented with menstrual irregularities only twice in the past 15 years. This possibly did not prompt her attending physicians to further evaluate the uterus as a cause of the irregular increase in abdominal size. This case was challenging to us as fibroids of this enormous size are rare, and hence, the first diagnosis of fibroid uterus was not made. Instead, it was suspected to be an ovarian carcinoma. Surgical challenges of access, intraoperative determination of anatomy, and hemorrhage were anticipated. Such large masses with uncertain diagnoses pose challenges for young and experienced surgeons alike. The patient was relieved after her treatment and was extremely thankful that she was acknowledged and not merely told that her problems were due to weight gain.

Preclinical utilization of the services of gynecologists in northern Germany depends on personal factors, such as family background, educational level, and socioeconomic status. Menstrual disorders are diverse in diagnosis and have organic and nonorganic reasons that require diagnostic clarification. Therefore, liberal utilization of physical and ultrasound examinations by general physicians could help prevent a delay in diagnosis and therapy of treatable causes such as fibroids. Giant fibroids remain a diagnostic and surgical challenge, requiring expertise and interdisciplinary cooperation. Nevertheless, these gigantic benign tumors can be managed complication-free with proper diagnosis and surgical expertise.

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Abbreviations

Body mass index

Computed tomography

Magnetic resonance imaging

Total laparoscopic hysterectomy

Laparoscopic-Assisted supracervical hysterectomy

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Department of Gynecology and Obstetrics, University Medical Center UKSH, Campus Kiel, Arnold-Heller-Straße 3, Haus C, 24105, Kiel, Germany

Wiesener Viva, Dhanawat Juhi, Andresen Kristin, Alkatout Ibrahim & Bauerschlag Dirk

Spectrum Clinic and Endoscopic Research Institute, 6A and 6B Neelamber building, Shakespeare Sarani, Kolkata, West Bengal, 700020, India

Dhanawat Juhi

Institute of Pathology, University Medical Center UKSH, Campus Kiel, Arnold-Heller-Straße 3, Haus C, 24105, Kiel, Germany

Mathiak Micaela

Department of Radiology and Neuroradiology, University Medical Center UKSH, Campus Kiel, Arnold Heller Straße 3, Haus C, 24105, Kiel, Germany

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VW: manuscript writing; JD: manuscript writing; KA: data collection; MM: histology workup, provided immunohistochemical figures; MB: radiology workup, provided CT scan figures; IA: manuscript editing, surgery; DB: manuscript editing, surgery, provided figures. All authors read and approved the final manuscript.

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Correspondence to Dhanawat Juhi .

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Viva, W., Juhi, D., Kristin, A. et al. Massive uterine fibroid: a diagnostic dilemma: a case report and review of the literature. J Med Case Reports 15 , 344 (2021). https://doi.org/10.1186/s13256-021-02959-3

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Received : 29 January 2021

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DOI : https://doi.org/10.1186/s13256-021-02959-3

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Case Study: A Challenging Fibroid Case—Avoiding Hysterectomy for Symptomatic Fibroids

Introduction.

Sara K.* is a 39-year-old woman with symptomatic fibroids causing quality of life limitations. Wanting to avoid a second myomectomy or hysterectomy, which would have been required because of the large uterine size, the patient underwent successful Uterine Fibroid Embolization (UFE) in January 2020.     

Case Presentation

The patient had experienced long menstrual cycles with menorrhagia, clots, fatigue, and dysmenorrhea for two years. She also had urinary frequency and constipation.

The patient had never been pregnant and did not plan a future pregnancy. She had a family history of symptomatic fibroids in her mother.

She was anemic and taking prescription iron and vitamins. Other diagnoses included hypothyroidism and vitamin D deficiency. She was also experiencing some depression due to the negative impact of her menstrual cycle in her daily life.

She required a 2-unit blood transfusion due to menstrual blood loss in January 2018. Her Hgb was 3. Depo-Provera was given but the injections made the symptoms worse.

She underwent a hysteroscopic myomectomy in March 2019, which provided only minimal relief of symptoms.

The patient was scheduled for a hysterectomy but did not want to undergo open surgery and miss weeks of work. Her gynecologist referred her to Dr. Suzanne Slonim. The patient lives in New York state and traveled to the Fibroid Institute Dallas for an office consultation.

“Sara’s quality of life was severely reduced because of the size and location of her fibroids. Traditionally, the only approach to significantly alleviate her symptoms would be a major surgery with a large incision or an extended robotic surgery. She also did not want to take so much time off from work in order to recover from her surgery. I knew at that time a referral to Dr. Slonim was the right call. We discussed all of her options, and ultimately Sara decided to come from New York to have Dr. Slonim perform the procedure. I am delighted that Sara got the relief she needed. I have always been able to rely on Dr. Slonim to bring critical relief to my patients who are ideal candidates for a UFE.” –Emil Tajzoy, MD, PLLC, Obstetrics & Gynecology in Dallas, 214-216-6713

Exam and MRI Findings

Dr. Slonim conducted a complete physical examination to determine the overall health of the patient, and to see if she was a candidate for Uterine Fibroid Embolization (UFE). A pelvic MRI with contrast showed an enlarged uterus and numerous fibroids. Most were small, but a dominant fibroid in the right posterior uterine wall measured 5.4 x 5.1 x 6.2 cm.

While predominantly intramural, the patient also had a submucosal component abutting the endometrium. There were also several smaller submucosal fibroids projecting into the endometrium. There were no apparent pedunculated subserosal fibroids and the endometrium was of normal thickness. The fibroids were predominantly iso-enhancing relative to the myometrium. The MRI also showed a small left ovarian cyst.    

Refer a Patient for UFE with Suzanne Slonim , MD

Hormone treatment and myomectomy did not relieve the patient’s symptoms from her fibroids. If anything, they were getting worse. The patient consulted with her gynecologist for a hysterectomy, thinking it was her only remaining option. However, after realizing the magnitude of her fibroids would require an open hysterectomy, she pursued alternatives.

Her gynecologist referred her to the Fibroid Institute Dallas to help her find relief. Found to be a candidate after examination, Dr. Slonim recommend UFE and advised the patient on risks, benefits, and alternatives to the procedure. The patient decided to proceed with UFE.

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Outcome/Results

The outpatient UFE procedure was successfully performed in January 2020. The patient experienced slight pain and nausea immediately after the procedure, but it did not last long.

Four months after UFE, the patient had a follow up tele-visit. She had intermittent bloating and vaginal spotting, but they were minor compared to her previous fibroid symptoms. She no longer needed prescription or over the counter pain medication. Her periods were much shorter and lighter, with greatly reduced cramping. She was able to resume an exercise routine and described feeling healthy. She is taking prescription vitamins and iron to build back up her blood supply.

Dr. Slonim advised the patient that her fibroids would continue to shrink, and her symptoms would continue to improve over time. She also advised the patient to follow up on the ovarian cyst and have it monitored locally.

“This case is a good example of how even large symptomatic fibroids can be treated without a hysterectomy. Providing the option of UFE allows you to offer a solution to your patient while accommodating her desire to avoid surgery.” –Suzanne Slonim, MD, Founder and Medical Director, Fibroid Institute Dallas

Fibroid Institute Dallas instructed the patient to follow up as needed. Sara K. was thrilled with the results of her UFE and said “It has been six months since the surgery, and my period is now minor and an afterthought. I went from having extremely heavy 6-10 weeklong periods to 4 days. I have my life back. I am so thankful to have found Dr. Slonim.”

Dr. Slonim Welcomes Your Challenging Fibroid Cases

Suzanne Slonim, MD created Fibroid Institute Dallas with your fibroid patient in mind. A board-certified interventional radiologist for 25 years, she has performed over 30,000 procedures. Dr. Slonim provides the patient consultation and orders imaging, if needed. She has developed a specific algorithm in how she treats patients, so they have a high success rate with minimal discomfort. In addition, referring to Dr. Slonim ensures no loss of your patients to competitors. You continue routine medical care with patients who are now fibroid free. Dr. Slonim is available to partner with you on your challenging fibroid cases.

For an in-person visit about the benefits of UFE for your patients as well as a physician packet with additional information for you and your patients, request a session with our VP of Marketing and Business Development, Stacey West.

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Case series: Pregnancy Outcome in Patients with Uterine Fibroids

Affiliations.

• 1 Senior Resident, Department of Obstetrics and Gynecology, ESI Post Graduate Institute of Medical Science and Research , Bangalore, India .
• 2 Assistant Professor, Department of Obstetrics and Gynecology, ESI Post Graduate Institute of Medical Science and Research , Bangalore, India .
• 3 Associate Professor, Department of Obstetrics and Gynecology, ESI Post Graduate Institute of Medical Science and Research , Bangalore, India .
• PMID: 26557577
• PMCID: PMC4625296
• DOI: 10.7860/JCDR/2015/14375.6621

Fibroids in pregnancy is a commonly encountered clinical entity. Objective of this study was to evaluate the maternal and fetal outcome in women having pregnancy with uterine fibroids. We present the clinical, obstetric data, perinatal outcomes of 15 patients from a prospective study. Fifteen pregnant women with fibroid >3cm were prospectively included in study. Major proportion of patient with fibroids were in younger age group of 25-30 years when compared to older age group of 31-35 years (66% vs 33%). Fibroids were more frequent in multi-gravidae, compared to primigravidae. In almost half of patients, (53.3%) fibroids were diagnosed before pregnancy. Common complications encountered during pregnancy in decreasing order of frequency were pain abdomen (46.6%), followed by threatened preterm labour (26.6%) and anaemia (26.6%). Out of 15, three (20%) women had abortion. In remaining, 11/12 patients attained term pregnancy between 37 to 40 weeks. Two patients required antenatal myomectomy. Caesarean section was done in 75% of women who attained term pregnancy and one patient had technical difficulty during caesarean section. Post partum heamorrhage was seen in 5/15 (33.3%) of patients. Out of 12, five babies were low birth weight. Four babies required NICU admission. There was no perinatal mortality. In our small patient series high incidence of caesarean section rates and increased incidence of threatened preterm labour, anaemia, and postpartum haemorrhage, was observed in pregnant patients with fibroids and hence, the pregnancy with fibroids should be considered as high risk pregnancy.

Keywords: Fibroids; Leiomyomas; Obstertric complications.

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[Table/Fig-7]:

A) Longitudinal ultrasound images showing live…

A) Longitudinal ultrasound images showing live intrauterine gestation; B) 2.5X2.5cm fibroid. This patient had…

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An Unusual Presentation of a Large Cervical Fibroid—Case Report

• Published: 15 October 2019
• Volume 1 , pages 969–971, ( 2019 )

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• Kavita Khoiwal   ORCID: orcid.org/0000-0002-3156-7486 1 ,
• Amrita Gaurav 1 ,
• Payal Kumari 1 ,
• Anupma Kumari 1 &
• Jaya Chaturvedi 1  

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Uterine fibroids are the commonest pelvic tumors of reproductive-age women, while the incidence of cervical fibroid is only 1–2%. We noted the patient’s clinical history, examination findings, diagnostic tools, management, and outcome. We report a 53-year-old parous lady who was initially diagnosed with malignant ovarian tumor on the basis of clinical manifestations and imaging findings. Intraoperatively, it turned out to be a large cervical fibroid. Total abdominal hysterectomy was performed without any intraoperative complications. Anticipation of complications and preventive measures during surgery are the key of successful outcome in large cervical fibroids. To avoid ureteric injury, preoperative stenting, intra-operative delineation of ureters, and dissection inside the fibroid capsule are the best principles.

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Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, Rishikesh, India

Kavita Khoiwal, Amrita Gaurav, Payal Kumari, Anupma Kumari & Jaya Chaturvedi

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Dr. Kavita Khoiwal, Dr. Amrita Gaurav, and Dr. Anupma Kumari have conceived the case report and performed the surgery. Dr. Payal Kumari retrieved and prepared CT scan images and HPE report. Dr. Kavita Khoiwal prepared the figures and wrote the manuscript. Dr. Jaya Chaturvedi guided throughout the patient management as well as in manuscript preparation. All authors read and approved the final manuscript.

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Khoiwal, K., Gaurav, A., Kumari, P. et al. An Unusual Presentation of a Large Cervical Fibroid—Case Report. SN Compr. Clin. Med. 1 , 969–971 (2019). https://doi.org/10.1007/s42399-019-00157-3

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Multiple uterine fibroids in an 18-year-old: a case report and review of literature

Department of Obstetrics and Gynaecology, Lagos University Teaching Hospital.   Idi-Araba, Lagos, Nigeria

Correspondence:   Opeyemi R Akinajo    [email protected]  

Submitted: June 2020     Accepted: September 2020     Published: November 2020

Citation:  Akinajo et al. Multiple uterine fibroids in an 18-year-old: a case report and review of literature. South Sudan Medical Journal 2020; 13(4):156-159 © 2020 The Author (s)  License: This is an open access article under  CC BY-NC-ND

Uterine fibroids are benign monoclonal neoplasms arising from smooth muscle cells in the uterine wall. They are common gynaecological tumours in women of reproductive age, but, a rare occurrence in adolescence.  

We present a case of a Nigerian 18-year-old undergraduate with abnormal uterine bleeding and abdominal swelling with a clinical diagnosis of uterine fibroids. She had an open abdominal myomectomy. Histology confirmed uterine fibroids. There is need for medical practitioners to consider this condition as a differential diagnosis especially among this group of women albeit a rare occurrence.  

Keywords: uterine fibroid, gynaecological tumours, reproductive age, myomectomy, Nigeria

Introduction

Uterine fibroids are the commonest benign gynaecological tumour arising from the smooth muscle cells. [1,2] They are usually firm, well demarcated whorled tumours and have been found to occur in 70-80% of women before or by the onset of menopause. [2,3] The prevalence increases with age, and although it has been reported rarely in adolescents, the exact aetiology of a leiomyoma is not clearly understood. A number of risk factors have been implicated. [4] In adolescents, it is hypothesised that ovarian activation, genetic characteristics, prenatal hormone exposure, growth factors could predispose to the development of leiomyomata. [2,3,5]  

The presentation and clinical features of uterine fibroids depends on the size and location. [5] Among the women diagnosed with leiomyoma the majority will be asymptomatic and will not require treatment. [1,2,5] However, in symptomatic cases, abnormal uterine bleeding is the most frequent complaint, the commonest of which is heavy menstrual bleeding. [5,6] Other symptoms include; abdominal pain, dysmenorrhoea, pressure effect, spontaneous miscarriage and infertility. [1,6]  

Case Report

An 18-year-old nulliparous undergraduate presented to our outpatient department with a history of heavy menstrual bleeding with passage of clots for one-year and a progressively increasing lower abdominal swelling of eight months’ duration. She used an average of six sanitary pads per day as against her usual three. The duration of her menstrual flow increased from three days to eight days with associated dysmenorrhoea severe enough to disturb her daily activities and sleep. There was no history of bleeding from other parts of her body, no easy bruising, and no history of intermenstrual bleeding. There were occasional episodes of palpitation and dizziness, but no syncopal attacks. There was no personal or family history of breast, ovarian, endometrial, or colon cancer. Her grandmother, mother, and two older sisters had a history of uterine fibroids. She had no chronic medical condition and attained menarche at ten years of age with a moderate flow for five days in a regular 28-day menstrual cycle, before the onset of present symptoms. She was virgo intacta .

Her general physical examination was normal apart from a degree of pallor. No abnormality was detected in the respiratory and the cardiovascular systems. Abdominal examination revealed no hepatomegaly, splenomegaly or palpable kidneys. A 20 weeks’ sized pelvic mass was noted. It was smooth, firm, regular and mobile. There was no ascites and bowel sounds were normal. Vaginal examination showed an intact hymen.   A diagnosis of symptomatic uterine fibroids was made with the differential diagnosis of an ovarian tumour.  

Full blood count showed a packed cell volume (PCV) of 26% and haemoglobin of 8.6g/dl. Her serum electrolyte, urea and creatinine, urine beta HCG and alpha- fetoprotein levels were within normal limits. Pelvic ultrasonography revealed an anteverted and markedly enlarged uterus with multiple well defined, hypoechoic solid masses of varying sizes, the largest measured 13.4cm x 8.5cm located in the fundus. Subserous and submucous components were also seen. Magnetic resonance imaging (MRI) of the pelvis could not be done due to financial constraints.  

She was subsequently counselled on different options of management in the presence of her parents and they opted for an open abdominal myomectomy. They were further counselled on the benefits as well as the associated risks, recurrence and future fertility. Informed consent was obtained. Intraoperative findings (Figure 1) were that of a 20-week sized fibroid riddled uterus with multiple sub-serous, intramural and submucous fibroids. Thirteen fibroid nodules were enucleated with the smallest size measuring 2cm and the largest 16cm. The fallopian tubes and ovaries were healthy. Estimated blood loss was 600mls.  

Figure 1. Fibroid riddled uterus (Credit: Dr Ugwu).

Her immediate post-operative period was uneventful and her vital signs remained clinically stable. Her postoperative PCV was 28.6% while her haemoglobin was 9.5g/dl. Her postoperative recovery was satisfactory and she was discharged home on the 4th postoperative day on iron, folic acid and vitamin B supplements. At her first follow-up visit two weeks later she was asymptomatic and the surgical site was well healed.  

At four weeks she had a PCV 30% and haemoglobin of 10g/dl. The histology report confirmed uterine fibroids. Though she was adolescent and not sexually active, she was still counselled on contraceptive options.  

Uterine fibroids are benign monoclonal tumours of smooth muscle cells of the myometrium composed of large amounts of extracellular matrix containing collagen, fibronectin, and proteoglycan. [7,8] They account for 3.2–7.6% of new gynaecological cases seen in gynaecology clinics. [9]   Fibroids have been reported in up to 70% of uteri   at hysterectomy. [7] They are uncommon in the adolescent age group. [7,8] The exact aetiology of uterine fibroids has not been fully elucidated. However, cytogenetic and genetic studies suggest that they result from somatic mutations in myometrial cells with aberrations involving chromosomes 6,7,12 and 14. [7,8] These chromosomal aberrations are not present in all the fibroids in a single uterus suggesting that there may be other explanations in the pathogenesis. [7]

Each fibroid is believed to be monoclonal in origin and arises from a single muscle cell. [8] It has been established that the growth of these fibroids   is closely dependent on ovarian steroids. [7,8] Abnormalities in uterine vasculature and angiogenic factors have also been implicated as fibroids have a rich blood supply. [7]   Known risk factors for uterine fibroids includes: black race, nulliparity, obesity, familial predisposition,   polycystic ovary syndrome, diabetes and hypertension. [8,10] The risk factors identifiable in this patient include being of the black race,   positive first- degree relative family history of uterine fibroids, nulliparity and being of reproductive age. High consumption of red meat (beef), as a source of extra oestrogen, has been noted to increase the likelihood of developing uterine fibroids by 1.7 fold. [10,11]  

Fibroids can be classified by their anatomical location in the uterus: intramural, sub-serous, sub-mucous, cervical, intra-ligamentary, pedunculated or parasitic in which case the leiomyoma has acquired an extrauterine blood supply usually from the omentum with atrophy and resorption of its pedicles. [7,8] The International Federation of Gynaecology and Obstetrics (FIGO) classification can also be used to classify them. [12,13]  

The clinical features of uterine fibroids depends on the size and location. [8] Although they maybe asymptomatic in up to 70% of cases heavy menstrual bleeding is the commonest symptom [8] as in our patient. The possible mechanisms by which fibroids may cause menorrhagia include: enlargement of the surface area of the uterine cavity, congestion and dilatation of endometrial venous plexuses, imbalance in uterine prostaglandin production and disturbances in normal myometrial contractility. [8] Patients may also present with chronic pelvic pain, dysmenorrhoea, dyspareunia, pelvic pressure, urinary symptoms and rarely venous thrombosis and constipation or intestinal obstruction from recto-sigmoid compression. [7,8,10]  

Diagnosis of uterine fibroids can be made following a good history and physical examination. Ultrasound scans (especially transvaginal) remain invaluable first-line imaging modalities. [7,8] This patient however had a trans-abdominal pelvic ultrasound done because she was virgo intacta.  

Management can be conservative, medical, or surgical. Asymptomatic patients are managed conservatively. This involves explanation, reassurance, and re-examination at periodic intervals. [8] In symptomatic cases, with menorrhagia, anaemia if found should be corrected. Tranexamic acid, combined oral contraceptives or levonogestrel releasing intrauterine device can be used to reduce menorrhagia. [7,8] Gonadotropin-releasing hormone (GnRH) analogues cause temporary regression of fibroids by decreasing estrogen levels. [7,8] GnRH analogues are typically used for a maximum of   six months due to their side effects such as vasomotor symtoms, osteoporosis and other common postmenopausal symptoms. [7,8] These side effects especially vasomotor symptoms can become so severe to require add-back therapy with primarin or combined oral contraceptives. [7,8] Hence the main use of GnRH is to reduce the size of fibroid preoperatively in order to minimize intraoperative blood loss. [8]  

The selective progesterone receptor modulator ulipristal acetate has shown remarkable results in effectively reducing pain, bleeding and fibroid size without producing oestrogen deficiency symptoms like hot flushes. [7,8]  However, prolonged use of this drug is discouraged as fulminant hepatic failure has been noted in some patients after prolonged use. [7] Surgical methods of management include myomectomy, hysterectomy, myolysis, uterine artery embolization and bilateral uterine artery ligation. [7,8,14,15]

Myomectomy can be via open abdominal surgery or endoscopic surgery (laparoscopy, hysteroscopy). [7,8] The surgical method of choice depends on the age of the patient, the size of the fibroid, the severity of symptoms, the desire for fertility, and the skill of the surgeon. [8,14] Surgical options of management such as hysterectomy, uterine artery embolization and ablation procedures are reserved for women who have completed their family sizes.  

This patient would have benefitted from a laparoscopic myomectomy based on the fact that it is a minimally invasive procedure with little or no risk of adhesions that might complicate future fertility. However, she had an open abdominal myomectomy because her fibroids were relatively large and she was virgo intacta.   There is a risk of recurrence following myomectomy hence hysterectomy is considered the definitive treatment for uterine fibroids. [7]  

Management of symptomatic uterine fibroids in an adolescent can be difficult as the clinician is faced with the major challenge of preserving the fertility of the patient, the plausible risk of recurrence and the attendant complications of surgery which include adhesion formation and increased   need for Caesarean delivery in the future. Irrespective of the above, myomectomy still remains the preferred management option in this group of young patients.

This was a case of an adolescent with multiple uterine fibroids. Uterine fibroids should be in the differential diagnosis list when evaluating adolescent women who present with a pelvic mass, abnormal uterine bleeding and abdominal pain. This group of women should be adequately counselled on the different options for management with the ultimate goal of preserving their future reproductive career.

Conflict of interest: None declared.

Consent for publication: A written informed consent was obtained from the patient before publication of this case report and accompanying image.

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• Kayadibi Y, Ozmen E, Emir H, Emre S, Dervisoglu S, Adaletli I.   Subserosal leiomyoma of uterus mimicking an ovarian tumour in adolescent patient. Japanese Journal of Radiology 2013; 32(1):48–52.  
• Bassey D, Dianabasi, Inah G, Ekott M. Prevalence of uterine fibroid among adolescent school girls in Calabar, Nigeria. IOSR-JDMS. 2016;15(3):74-75.  
• Van den Bosch T. Benign disease of the uterus. In: Edmomds DK, Lees C, Bourn T, eds. Dewhurst’s Textbook of Obstetrics and Gynaecology, 9th edition. Oxford; Wiley-Blackwell Publishing Inc. 2018. p. 823-834.
• Kwawukume EY, Ekele BA, Danso KA, Emuveyan EE. Editors. Comprehensive Gynaecology in the Tropics. Accra: G-pak Limited: 2017; p. 173-186.
• Garba I, Ayyuba R, Adewale TM, Abubakar IS. Surgical management of uterine fibroids at Aminu Kano Teaching Hospital. Niger J Basic Clin Sci 2016;13(1):50-4.
• Bizjak T, Bečić A, But I. Prevalence and Risk Factors of Uterine Fibroids in North-East Slovenia. Gynecol Obstet (Sunnyvale) 2016;6:350. doi:10.4172/2161-0932.1000350.
• Pavone D, Clemenza S, Sorbi F, Fambrini M, Petraglia F. Epidemiology and risk factors of uterine fibroids. Best Practice & Research Clinical Obstetrics & Gynaecology 2018;46:3-11.  
• Munro MG, Critchley HO, Fraser IS. The FIGO classification of causes of abnormal uterine bleeding in the reproductive years. Fertil Steril 2011; 95(7):2204-2208.  
• Munro MG, Critchley HO, Fraser IS. The flexible FIGO classification concept for underlying causes of abnormal uterine bleeding. Semin Reprod Med 2011;29(5):391-399.
• Ernest A, Mwakalebela A, Mpondo BC. Uterine leiomyoma in a 19-year-old girl: Case report and literature review. Mal. Med J. 2016;28(1):31-3.
• Diesen DL, Price TM, Skinner MA. Uterine leiomyoma in a 14-year-old girl. Eur J. Pediatr Surg. 2008;18(01):53-5.

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Meta-Analysis: Is Vitamin D Linked to Uterine Fibroid Presence and Size?

BACKGROUND AND PURPOSE:

• Previous studies have found that vitamin D levels may influence the risk of uterine fibroids, and that vitamin D therapy may reduce fibroid size or recurrence
• Ivanova et al. (Journal of Obstetrics and Gynaecology Canada, 2024) consolidated existing literature regarding the association between vitamin D and uterine fibroid presence and growth
• Systematic review and meta-analysis
• Randomized or observational studies
• Studies that evaluated serum vitamin D levels or vitamin D treatment effects | Used ultrasonography for diagnosis | Involved ≥25 premenopausal participants
• Risk of bias was assessed
• Quality of evidence was assessed with GRADE criteria
• Meta-analysis was performed with random effects modeling
• Fibroid size, as percentage change in diameter or volume
• Serum vitamin D levels
• 3 RCTs and 23 observational studies | 328 and 5650 participants
• Standardized mean difference (SMD) –5.7% (95% CI, –10.63 to –0.76) | P=0.02 | I2 =99%
• MD –5.50 ng/mL (95% CI, 6.99 to –4.01) | P<0.001 | I2=87%
• Odds ratio (OR) 3.71 (95% CI, 1.90 to 7.24) | P<0.001 | I2=80%

CONCLUSION:

• Patients with uterine fibroids have lower vitamin D levels and vitamin D supplements can reduce fibroid size
• The authors state

Future trials with long-term follow up are needed to refine optimal dosing, duration, and side effect profile of prolonged supplementation These trials will provide essential data for guiding clinical practice Presented findings may be beneficial for patients seeking risk reduction without hormonal modification or those seeking a non-invasive approach for existing fibroids

Learn More – Primary Sources:

The Association of Vitamin D with Uterine Fibroids in Premenopausal Patients: a Systematic Review and Meta-Analysis

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Health | New outpatient procedure for uterine fibroids…

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Health | New outpatient procedure for uterine fibroids is changing women’s lives

Now there’s another way.

Through laparoscopic radiofrequency ablation (Lap-RFA) women have a viable and considerably less invasive option, for the treatment of uterine fibroids should they choose to seek a diagnosis and treatment.

But will they?

Dr. Jay Fisher, a Corewell Health obstetrician-gynecologist pioneering the treatment in Southeast Michigan, also known as the Acessa procedure, said up to 75 million women in the United States may experience symptoms caused by uterine fibroids, but only 1.4 million will seek care for it.

“Most of them just live with it,” Fisher said.

Once a month these women suffer a variety of symptoms such as excessive menstrual bleeding, cramping and anemia and, while a laparoscopic hysterectomy is less invasive, it still requires the surgical removal of the uterus, or womb, from a woman’s body. Plus, a lot of women are unable to take the medication (estrogen) that was typically prescribed afterwards.

Laparoscopic radiofrequency ablation (Lap-RFA) was  first used in the treatment of liver tumors uses radiofrequency energy to treat uterine fibroids.

“It’s really remarkable technology because it’s very precise, delivering (the radiofrequency) directly to the fibroid itself while not damaging any tissue around it.”

Among those who were trying to live with the symptoms caused by uterine fibroids was Balsam Goriel, 47, of Warren.

“Every other month I would be in the emergency room,” said Goriel, whose condition got so bad it required blood transfusions.

“It was exhausting,” she said. “I wouldn’t go anywhere. I barely ate. I was like a car without lights.”

Her doctor tried a procedure that has had some success but it didn’t work for her and it appeared that her only option would be a hysterectomy, which she was not ready to accept.

“I don’t like getting my periods but I think it’s like a detox for a woman,” Goriel said. “It wasn’t about having children.”

It’s then she was told about laparoscopic radiofrequency ablation (Lap-RFA), which at one time was not covered by many health insurance plans. However, in recent years data has shown that it’s not only an effective treatment medically, but also financially more cost effective.

“It’s the best thing I’ve ever done. Dr. Fisher was amazing. He worked hard to identify the right solution for me,” she said.

The renewed energy she experienced after the outpatient procedure enabled her to return to a normal life.

“I have not gone to the ER since,” she said, adding she has not had to call in sick to work as well. She is socializing, happy and robustly practicing the tenets of self-care such as walking and exercise, journaling, prioritizing water intake, a solid sleep routine and a diet rich in fruits and vegetables.

“It’s the best thing I’ve ever done,” said Goriel. “I still get cramps but it’s nothing like it used to be. Now, I just have the same discomfort as everyone else.”

For more information visit beaumont.org/services/doctors .

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H.R. 8247: Uterine Fibroid Intervention and Gynecological Health Treatment Act of 2024

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The text of the bill below is as of May 6, 2024 (Introduced).

118th CONGRESS

IN THE HOUSE OF REPRESENTATIVES

May 6, 2024

Ms. Brown (for herself, Ms. Clarke of New York , Mrs. Cherfilus-McCormick , Ms. Lois Frankel of Florida , Mrs. Beatty , Mr. Jackson of Illinois , Ms. Norton , Ms. Jackson Lee , Ms. Kamlager-Dove , Ms. Kelly of Illinois , Mrs. Hayes , Mrs. Trahan , Mr. Lieu , Mr. Frost , Ms. Stevens , Mrs. Watson Coleman , Mrs. Ramirez , Ms. Moore of Wisconsin , Ms. Strickland , Ms. Jacobs , Mr. Veasey , Ms. Williams of Georgia , Mr. Grijalva , Ms. Jayapal , Ms. Plaskett , Ms. Pressley , Ms. Sewell , Mr. Johnson of Georgia , Mr. Casar , Mrs. Foushee , Ms. Blunt Rochester , Mr. Carson , and Ms. Budzinski ) introduced the following bill; which was referred to the Committee on Energy and Commerce

To authorize the Secretary of Health and Human Services to award grants to increase early detection of and intervention for uterine fibroids, and for other purposes.

Short title

This Act may be cited as the Uterine Fibroid Intervention and Gynecological Health Treatment Act of 2024 .

Research on uterine fibroid early detection and intervention

The Secretary of Health and Human Services (in this Act referred to as the Secretary ) shall—

conduct or support research on increasing early detection of, and intervention for, uterine fibroids; and

based on the results of such research and other relevant information, formulate evidence-based or evidence-informed strategies to increase early detection in health care settings.

The Secretary shall finalize the evidence-based or evidence-informed strategies required by subsection (a)(2) as expeditiously as possible in order to make such strategies available to grantees under section 3 to implement such strategies pursuant to section 3(b)(3).

Grants with respect to uterine fibroid early detection and intervention

The Secretary of Health and Human Services (in this Act referred to as the Secretary ) may award grants to States for carrying out programs—

to increase early detection of and intervention for uterine fibroids; and

to develop and implement public awareness and education campaigns for the early detection and intervention of uterine fibroids.

Use of funds

A State receiving a grant under this section may use the grant, with respect to increasing early detection of and intervention for uterine fibroids, for the following activities:

Screening procedures, including advanced gynecological imaging (including payment therefor).

Patient navigation services.

Implementation of evidence-based or evidence-informed strategies proven to increase early detection in health care settings.

Facilitating access to health care settings.

In awarding grants under this section, the Secretary shall give priority to States proposing to carry out a program in a geographic areas in which there are socially vulnerable populations with elevated risk of uterine fibroid development.

Research with respect to uterine fibroid early detection and intervention

The Secretary may award grants to conduct research, which may include clinical trials, related to—

disparities in pain control and management in uterine fibroid surgical treatment; or

Asherman’s Syndrome, intrauterine adhesions, and other intrauterine conditions as determined appropriate by the Secretary.

Reports to Congress

Reports on grants

Not later 2 years after the initial award of grants under this Act, and every 2 years thereafter, the Secretary shall submit to the Congress, and make publicly available on the appropriate website of the Department of Health and Human Services, a report summarizing the findings and results of programs and activities funded through grants under this Act.

Report on research developments

Not later than 2 years after the date of enactment of this Act, and every 2 years thereafter, the Secretary shall submit to the Congress, and make publicly available on the appropriate website of the Department of Health and Human Services, a report outlining research developments and findings related to—

disparities in pain control and management in uterine fibroid surgical treatment; and

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First child to be born from a transplanted uterus gives keynote speech at conference

by University of Gothenburg

An ordinary boy who loves sports. This is how 10-year-old Vincent introduced himself when he spoke to leading international uterus transplantation researchers in Gothenburg. Vincent was the first baby to be born from a transplanted uterus.

The world's first birth following a uterus transplantation took place on September 4, 2014, as part of a research project at Sahlgrenska Academy at the University of Gothenburg. The mother gave birth at Sahlgrenska University Hospital in Gothenburg, and the baby boy was named Vincent.

Ten years later, he gave the keynote speech in English to uterus transplantation experts from six continents, who had gathered for a scientific conference in Gothenburg beginning on Thursday. Vincent's inclusion as a speaker was a welcome surprise/surprise, and drew a round of applause.

"I am a regular boy who loves sports, especially golf. My favorite subject in school is Art. When I grow up, I want to be a golf pro, he says from the stage. My mom and dad are here with me today, and I know they and the Swedish team and doctors are very proud of me. I am very happy that I am here because of all the brave people in this room."

Surgical techniques and well-being

Following Vincent's birth in 2014, six more babies were born within the same research project before a mother outside Sweden gave birth after a uterus transplantation. Today, the number of transplants performed worldwide has been estimated at around 120, and just over 60 children have been born—including 17 in Sweden.

Alongside refined surgical techniques —a key area when accumulating expertise—there is also a focus on the well-being of donors, recipients, partners and children. The research project at the University of Gothenburg monitors medical, psychological, and quality-of-life parameters of the study participants over a number of years. In the case of the children, this period lasts until adulthood.

In terms of the actual operations, there has been a trend away from open surgery toward robot-assisted keyhole surgery , especially for donors, who have often been the mothers or close relatives of the female study participants receiving transplants within the project.

Many years of research

Mats Brännström is Professor of Obstetrics and Gynecology at the University of Gothenburg's Sahlgrenska Academy, a gynecologist and consultant at Sahlgrenska University Hospital, and one of the lead researchers.

"Safe surgery and a quick recovery with the possibility to return to work and normal life are important for donors who undergo extensive surgery to help another woman," he explains. "Looking ahead, we can expect donors not to be close relatives, but perhaps people who donate through altruistic, anonymous donation."

Another leading member of the team behind the uterus transplantations in Gothenburg is Pernilla Dahm-Kähler, Adjunct Professor of Obstetrics and Gynecology at the University of Gothenburg's Sahlgrenska Academy, and a gynecologist and consultant at Sahlgrenska University Hospital.

"Previously, there was no way to help women to be able to give birth if they were born without a uterus or after surgical removal of uterus because of cancer or life-threatening bleeding," she says. "However, that has now changed thanks to years of intensive, successful research. We now have reliable data that we can take forward in our further research and in future health care applications."

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Myers E, Sanders GD, Ravi D, et al. Evaluating the Potential Use of Modeling and Value-of-Information Analysis for Future Research Prioritization Within the Evidence-Based Practice Center Program [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2011 Jun. (Methods Future Research Needs Reports, No. 5.)

Evaluating the Potential Use of Modeling and Value-of-Information Analysis for Future Research Prioritization Within the Evidence-Based Practice Center Program [Internet].

Case study: uterine fibroids.

Uterine leiomyomata, or fibroids, are benign tumors of the uterine smooth muscle and extracellular matrix and are extremely common in women of reproductive age. Using sensitive imaging techniques, cumulative incidence is as high as 70 percent among white women and more than 80 percent among African -American women by age 50. 46 Most fibroids are asymptomatic; however, in those women with symptoms such as pain or heavy menstrual bleeding, there are limited treatment options. Hysterectomy is curative (in fact, fibroids are the leading indication for hysterectomy in the United States), but there is significant interest in identifying effective alternatives to hysterectomy. 1 , 12 , 47 , 48 Given the high burden of disease (including substantial medical and nonmedical costs 49 , 50 ), significant differences in treatment choices and outcomes among population subgroups, local variation in rates of certain treatments such as hysterectomy, 51 and a range of medical and invasive treatments, management of uterine fibroids is an obvious area for comparative effectiveness research.

The Duke EPC conducted a systematic review on management of fibroids in 2001 that concluded that there was essentially no high-quality evidence available for making decisions regarding the most appropriate treatment for specific patients. 12 As part of the report, there was a detailed list of suggested research questions to address the existing evidence gaps. Subsequently, the Research Triangle Institute/University of North Carolina at Chapel Hill (RTI/UNC) EPC conducted an update in 2007 and noted that “[t]he current state of the literature does not permit definitive conclusions about benefit, harm, or relative costs to help guide women’s choices,” 48 with little change noted in the identified evidence gaps.

In 2009, AHRQ awarded a contract to the Outcome DEcIDE Center to develop a specific research agenda for comparative effectiveness research for management of uterine fibroids. 1 As part of this process, Outcome, working with the Center for Medical Technology Policy (CMTP), conducted a priority-setting exercise with a number of stakeholders; Dr. Myers served as co -chair of the Technical Working Group for this project. The large stakeholder meeting took place in March 2010. Because the Duke EPC had developed a decision model as part of the original 2001 report, which was also led by Dr. Myers as principal investigator (PI), the coincident timing of the AHRQ fibroid research agenda project and this project on broader issues in priority setting allowed us to incorporate a pilot exercise comparing the results of the modified Delphi process used with the large group of stakeholders to a formal decision model/VOI analysis.

Simulation Model

The model is a substantial update of one developed for the 2001 Duke EPC Evidence Report on management of uterine fibroids. 12 At that time, we concluded that “the lack of data necessary to validate, calibrate, and test this model is striking,” although we were able to perform a relatively simple “proof-of-principle” analysis comparing relief of symptoms with watchful waiting, hysterectomy, or myomectomy (removal of the fibroids themselves while preserving the uterus). In sensitivity analysis, the main drivers of effectiveness were the probability of menopause and the likelihood of development of new symptoms after hysterectomy.

Our updated model is structurally similar to the previous one ( Figure 3 ). Details of the model structure, assumptions, input parameters, and the rationale for our choices are described in detail in Appendix F . Although we attempted to make the model structure as flexible as possible to allow further development as a tool in fibroids research, our focus was primarily on the stakeholders’ perceptions of the potential usefulness of the VOI analysis in priority setting rather than on the results of the VOI analysis themselves. In addition, we had time and resource constraints that were similar to those that would be operational if a model were done as part of a CER. Because of this focus and these constraints, we simplified the model and the analysis in a number of ways to facilitate timely completion of the analysis and reasonably simple presentation to the stakeholders

Schematic diagram of fibroids model.

Although population-level values for EVPI and EVPPI would be preferable for purposes of decisionmaking about research investments, we focused this initial analysis, including the results presented to the stakeholders, on individual-level EVPI and EVPPI. Although most of the recent examples of the use of VOI in research prioritization have focused on population-level values, individual level EVPPI can be also be used as a form of sensitivity analysis. 5 , 6 , 10 , 52–54 We chose this approach for several reasons:

• As discussed in the detailed description in Appendix F , the model itself is still something of a work in progress, particularly regarding the potential interaction between the natural ovarian aging process as women approach menopause and treatment efficacy. In addition, the potential impact of incorporating reproductive outcomes into assessing treatment effectiveness for fibroids has not been previously explored. Because of this, we wanted to gain preliminary insight into structural aspects of the model, both to set the stage for further development and to be able to put the results in context for the stakeholders.
• Our primary goal in this case study was to obtain some sense from stakeholders about the potential utility of simulation modeling/VOI as part of a research prioritization process, especially in comparison to the recently completed consensus-based process. 1 Our experience working with stakeholders (or reviewers) with primarily content expertise who are unfamiliar with modeling is that considerable time and effort must be spent on explaining the underlying model structure and assumptions, and providing as much information as possible to ensure confidence in the face validity of the model. By being able to explain how different clinical or epidemiologic parameters affected the per-patient EVPI or EVPPI, we were able to demonstrate that many of the results were consistent with our current understanding of fibroids management.
• Although study feasibility was one of the factors stakeholders were asked to consider during the consensus-based priority setting, explicit discussions about sample size or available budget for specific research areas were not a major part of the process. We were most interested in comparing the relative ranking from the model-based analysis to that generated by the consensus-based process, which we were able to do with patient-level values. Incorporating population-level values would have provided additional information beyond the relative rankings and would certainly be helpful in discriminating between the highest ranking areas.
• There is uncertainty about the size of the potential affected population to be used for population-level estimation. A substantial number of procedures are performed on an outpatient basis, but, because of a lack of national data on outpatient procedures and substantial regional variation in the ratio of inpatient to outpatient procedures, 1 reliable estimates are difficult. Although an inpatient-based value would provide a lower bound and would be reasonable for the purposes of EVPPI comparisons, we elected not to incorporate this additional level of uncertainty for the purposes of the pilot exercise.

Briefly, the model is a Markov simulation that begins immediately following treatment for symptomatic fibroids. The model uses 1-week cycles and follows women for 3 years (based on the available long-term data on treatments of interest) or until age 45. We chose to stop the simulation at age 45 both because we were interested in pregnancy, which is rare after age 45, and to avoid the need to develop a method for modeling the interactions of natural menopausal changes in ovarian function and treatment effects, given our project timetable. We compared outcomes after myomectomy, uterine artery embolization (UAE), or magnetic resonance imaging (MRI)-guided focused ultrasound (FUS), based on published results (but not from a formal systematic review). We chose these three treatments based on current treatment patterns and interest expressed at the larger stakeholder meeting. We did not include long-term complications in the model, both to simplify modeling and presentation and because of a lack of data.

Our primary focus was on several broad areas at the top of the priority list identified by the larger stakeholder group—reproductive outcomes, relative recurrence rates, and the impact of recurrence on quality of life. In order to simplify both the analysis and the presentation, we did not attempt to model all of the possible options for managing recurrent symptoms. Instead, “recurrence” was an absorbing state in the model, with a wide range of possible costs and utilities associated with having recurrent symptoms.

The model was run as a microsimulation, using an age and racial distribution similar to a large prospective registry of women undergoing UAE, 55 and using age- and race-specific probabilities and nonmedical costs as described in detail in Appendix F . For each analysis, we performed between 600 and 10,000 simulations, drawing from the described distributions for each variable. We first performed a cost-effectiveness analysis from a societal perspective, using incremental cost/QALY as the primary outcome, followed by probabilistic sensitivity analyses using net monetary benefits across a range of willingness-to-pay thresholds from $0 to $100,000/QALY. We then estimated the EVPI for the entire model, followed by the EVPPI for individual variables or groups of variables. This was done by “fixing” the value (usually at the mean) of the variables of interest, then repeating the microsimulation using the remaining variable distributions. The EVPPI values for selected variables of interest were then ranked in descending order. Again, given time constraints, we did not estimate EVPPI for all possible variables, but focused on those identified as important by the modified Delphi process described below. As discussed above, we focused on the effects of different parameters on individual-level EVPPI in our initial review and interpretation of results, and in our presentation to the stakeholders.

Modified Delphi Process (by Outcome DEcIDE Center and CMTP)

The process used to develop a research agenda is described in detail in the Outcome report. 1 Briefly, a Technical Working Group (TWG) subcommittee of eight members with expertise in various aspects of fibroid research and treatment was assembled to provide technical expertise and develop a relatively focused group of research questions for discussion by a larger Stakeholder Committee of 34 members.

The TWG narrowed the list of evidence gaps identified from previous systematic reviews, translated these gaps into specific research questions, identified ongoing or planned studies that were relevant to specific questions, and helped develop background materials for the larger group. First, the TWG scored the initial list of questions using priority-setting criteria developed by Outcome and CMTP. The TWG then met to discuss and refine the questions, followed by rescoring. Based on this second scoring, a list of the top 12 research questions, along with general and question-specific background materials, was distributed to the larger Stakeholder Committee.

The Stakeholder Committee’s main objective was to generate a ranked list of research questions related to management of uterine fibroids. Each question was presented by a member of the TWG, with opportunities for discussion and questions. At the end of the meeting, members voted and generated a prioritized research agenda for uterine fibroids.

Comparison of Modified Delphi Process and VOI

We invited nine stakeholders who had participated in the earlier process to review the results of our VOI analysis and provide feedback on the usefulness of the VOI. These stakeholders were selected to provide diversity of backgrounds and included a gynecologist, an interventional radiologist, a health economist, a patient advocate, an endocrinologist working in industry, a representative from a large third-party payer, the Principal Investigator of the Outcome project, and representatives from the National Institutes of Health (NIH) and AHRQ.

The stakeholders were provided background materials prior to the call, including the detailed description of the model included as Appendix F and several review articles on VOI analysis, as well as a copy of the slide presentation given during the conference calls.

Three 1-hour conference calls were held to accommodate schedules, during which the a slide presentation was given which covered:

• The background of the project and the main purposes of the project—specifically, to assess the feasibility of VOI in a clinical area with a notably low level of quality evidence, to get input from them on the potential utility of VOI as a substitute or complement to the consensus-based process, and to get input on the optimal timing of VOI if done as part of a larger, multimethod priority-setting process.
• A brief description of the model and the use of sensitivity analysis as a technique to quantify the impact of different parameters on outcomes
• A brief definition of cost-effectiveness and net monetary benefits
• A brief description of VOI, which introduced the concepts of EVPI and EVPPI. Specifically, stakeholders were told that VOI was a method for estimating the value of future research, that population-level values could be used to generate research budgets, and that EVPPI was a method for ranking the relative importance of individual parameters within the model.

Each call was recorded and stakeholder feedback elicited. A brief survey was subsequently sent to the stakeholders to provide an opportunity for further structured feedback. Given the small numbers of participants, we did not formally quantify survey responses.

Model Results

We emphasize that these results are preliminary and that further model refinement and additional analyses may change the results.

Table 5 presents the mean and standard deviations for expected recurrences and reproductive outcomes from the initial model runs, assuming that 25 percent of patients would attempt pregnancy within the first year after treatment and that there are no differences between treatments on reproductive outcomes.

Expected recurrences and reproductive outcomes from initial model runs.

The high degree of uncertainty in the parameter estimates is reflected in the very wide standard deviations. Not surprisingly, pregnancy and live birth rates were relatively low, and preterm birth rates were high. Women in their 30s and 40s are less likely to get pregnant and more likely to have a miscarriage, resulting in low live birth rates, while African-American women, who make up approximately half of the population of women receiving fibroids treatment, are more likely to experience preterm delivery, especially at older ages (for example, a 44-year-old black woman is three times as likely to have a preterm delivery than a 25 -year-old white woman— see Appendix F ). The low pregnancy rates create a challenge for studying the effect of different fibroid treatments on reproductive outcomes, since a very large number of women actively seeking to get pregnant would be needed to identify clinically meaningful differences in outcomes. In order to simplify the analysis and presentation, we elected not to further explore the potential impact of differences in treatments on reproductive outcomes in the VOI analysis—the only pregnancy-related variable left in the model was time between initial treatment and the start of attempts to achieve pregnancy. We kept this variable because it was independent of any treatment effects on reproductive outcomes and, given our underlying assumptions, pregnancy and recurrent symptoms were important competing risks.

The overall EVPI per patient for the model as constructed ranged from $1,050 at a willingness-to-pay threshold of $50,000/QALY to $1,460 at a threshold of $100,000/QALY, reflecting the high degree of uncertainty for most of the model parameters. Table 6 shows the results of the EVPPI for selected variables:

Patient-level EVPPI for selected variables.

The majority of the variables considered had EVPPIs close to the overall EVPI, and given the high degree of uncertainty, the observed differences in the estimates may well be insignificant. However, factors related to recurrence and quality of life after recurrence were major drivers of uncertainty.

We then compared the overall EVPI for different mutually exclusive subpopulations of interest—first, white versus African-American women, and, second, women who desired future pregnancy versus those who did not ( Figure 4 ). The overall EVPI across the range of willingness-to-pay thresholds was slightly lower for white women than for African-American women. The major modeled differences between white women and African-American women were older age, higher wages, and overall better reproductive outcomes for white women; we did not model other consistent differences, such as more severe symptoms and more extensive disease among African-American women. Given that we constrained the simulations to 3 years or reaching age 45, the lower overall EVPI for white women likely reflects an older mean age, resulting in a greater number of women reaching the end of the simulation before an opportunity for recurrence.

Expected value of perfect information (EVPI) in select subpopulations of patients. (A) white women vs. (B) African-American women, and (C) women desiring future pregnancy vs. (D) women who have completed childbearing. WTP = willingness-to-pay. Comparisons (more...)

Differences between women desiring pregnancy and those not were much more substantial, with the EVPI for women desiring pregnancy less than half that for women not desiring pregnancy across all levels of willingness to pay. This is largely because, based on our initial results showing an overall low event rate for pregnancy outcomes, we did not model potential treatment-specific differences in reproductive outcomes in this iteration of the model—incorporating uncertainty about the relative impact of different treatments on reproductive outcomes would likely have had a significant impact on the EVPI for this population. Our assumptions that women would not attempt pregnancy while experiencing recurrent symptoms (and, conversely, that recurrent symptoms would not occur during pregnancy), and that a successful pregnancy had a utility similar to relief from symptoms, likely also played a role. Under these assumptions, pregnancy is a competing risk for recurrence, so that overall recurrence rates are lower, and subsequent quality-adjusted life expectancy is higher, among women attempting pregnancy. Since the EVPPI analysis showed that factors related to recurrence were the largest drivers of uncertainty, it is not surprising that the overall EVPI would be lower for a subgroup where recurrence risk is inherently lower. This competing risk effect also explains why time to attempt pregnancy was one of the highest ranking variables in the EVPPI analysis.

Comparison of Model Results to Qualitative Exercise

The top five research priorities identified by the Stakeholder Committee at the end of the modified Delphi process 1 were:

• What is the relative effectiveness of available interventional procedures (e.g., UAE) on durability of symptom relief and patient-reported outcomes?
• What is the relative effectiveness of interventional procedures versus noninterventional approaches as initial therapy on durability of symptom relief and patient-reported outcomes?
• Can we create validated and reliable classification systems of standard anatomic staging to use in research and clinical care of women with uterine fibroids?
• Can we create validated and reliable classification systems of patient-reported outcomes (including patient preferences, disease-specific and general quality of life, and patient satisfaction) to use in research and clinical care of women with uterine fibroids?
• Can we create validated and reliable classification systems of measures of responses to specific symptoms (such as menstrual pictograms, menstrual diaries, hemoglobin) to use in research and clinical care of women with uterine fibroids?

As discussed above, the variables with the highest EVPPI were those related to recurrence and quality of life (in this case, utilities) after recurrence, suggesting relatively close agreement between the VOI analysis and the modified Delphi process in terms of the highest priority areas for future research. Because we did not exhaustively include all possible variables in the analysis, and because the EVPPI values themselves are quite similar, it is possible that this concordance may not be so close with further model development. Three of the top five topics related to development of classification/staging systems for use in comparative effectiveness research in fibroids; although we did not model measurement/classification, extending the model to include these types of parameters is certainly possible (for example, by considering an anatomic staging system as a type of prognostic test, and modeling uncertainty surrounding sensitivity, specificity, and reproducibility).

Stakeholder Feedback

In feedback provided during the conference calls and via written comments, all the stakeholders stated that the VOI exercise was useful. Common themes mentioned included:

• While none of the stakeholders felt that VOI was a substitute for the consensus-based process, all felt that VOI would be a useful complement, with the results either available as background material prior to the in-person consensus meeting, or with the VOI process being done independently and in parallel with a consensus-based process. One respondent noted that the results of a VOI analysis would be helpful in identifying specific decisions that had implications for research feasibility and design, which in turn would be helpful in focusing discussions among a diverse group of stakeholders.
• There was unanimous agreement that the most valuable aspect of the exercise was the opportunity to discuss the model and analysis with the analysts and other stakeholders. The actual results in terms of ranking of research priorities and relative quantification of different areas of uncertainty were also valuable. Although the details of the underlying model were useful to most respondents, this was of overall less importance.
• All of the respondents felt additional background material on VOI, either as a briefing document or an online resource, would have been helpful.
• Limitations

Model and Results

As stated above, our focus in this exercise was on updating the preexisting model sufficiently to allow conducting a limited VOI analysis for purposes of presenting those results, both alone and in the context of the results of an independent consensus-based research priority-setting process, to a select group of stakeholders with relatively limited experience with the concepts of cost-effectiveness analysis or VOI analysis. Given this focus and time and resource constraints, we made a series of decisions, detailed above and in Appendix F , which limit the direct applicability of these results to priority setting for research on uterine fibroid management. These include:

• Our sources for parameter estimates were not based on a formal systematic review, or on analytic methods such as network meta-analysis, which would have been preferred for generating comparative estimates across three different treatment options. 56 , 57
• We did not include all possible treatment options, including hysterectomy and medical therapies, in the analysis. We also simplistically modeled recurrence—a more sophisticated approach would be to include a range of possible treatment options for recurrent symptoms.
• We did not exhaustively estimate EVPPI for every variable in the model.
• We constrained our analysis to 3 years of followup or reaching age 45. It is possible that longer time horizons would have affected our results, and it is likely that incorporating a potential interaction between treatment effects and declining ovarian function with age would have had some substantial effects.
• We did not model potential differences between treatments on reproductive outcomes. It is likely that uncertainty surrounding these results would affect the EVPI for the minority of women who are interested in future pregnancy.
• We did not estimate population-level EVPIs as part of the formal analysis, for the reasons described above. We provide one overall preliminary estimate below for overall research into management of fibroids, but this is itself subject to the uncertainty surrounding the size of the affected population. Our estimates of EVPI for subpopulations, or our estimates for individual EVPPI, have more value at this point as indicators of how individual components of the model (differential age distribution between subpopulations, competing risks between pregnancy and recurrence, constraining the simulation to women under 45) are driving affecting the outcome, rather than as formal estimates of the upper limit of research funding for a particular area for further research.
• Overall population-level EVPI estimates would have allowed comparison of the value of future research in fibroids to future research in other clinical areas.

Comparison to Modified Delphi Process

Similarly, our comparison to the modified Delphi process used by the Outcome/CMTP team was limited by a number of factors:

• Our choice of topic was driven by the presence of a preexisting model, institutional experience with the topic, and serendipitous timing. However, because of the size and number of evidence gaps for this particular clinical area, the model resulted in large and closely clustered EVPPIs for a majority of the variables considered. A topic with more discrete evidence gaps might have resulted in more clear-cut model results, and allowed a more detailed comparison to the consensus-based results.
• Our stakeholder group was limited in size, due to both resource and regulatory constraints. Broader representation among the entire stakeholders would have been extremely helpful to get a better sense of the potential utility of VOI. The small sample size also precluded any quantitative assessment of stakeholder perceptions of VOI.
• Dr. Myers, who did most of the model development and analysis, was also chair of the TWG for the consensus-based process. Although his familiarity with the clinical topic, the underlying evidence gaps, and the workings and outcomes of the consensus-based process undoubtedly helped facilitate the VOI process, it is possible that an analyst less involved in the alternative process would have produced results which differed in some meaningful way from the current results.
• Although our top rankings were similar to those resulting from the modified Delphi process, it is possible that at least some of that agreement is due to decisions about the scope and structure of the analysis made in order to facilitate the comparative process. Comparison of results from a more fully developed model to those from the consensus-based process will be informative.
• Our results as presented emphasized the use of VOI as a type of sensitivity analysis for comparison of relative importance of different parameters. Providing population-level estimates of EVPI and EVPPI to the stakeholders, as would have been done in a fully developed VOI analysis, might have resulted in different feedback from the stakeholders.
• Discussion: Fibroids Case Study

Simulation Model Results

Although we do not believe the model results as presented are directly applicable to priority setting for uterine fibroids, the model does provide some valuable insights:

• The prioritization of specific areas for research is likely to differ between women interested in future pregnancy compared to those who have completed childbearing.
• Sample sizes required to determine differences in reproductive outcomes between treatments are likely to be fairly large.
• The overall EVPI for fibroids appears to be quite large. Comparison of EVPI results across different areas is difficult for a number of reasons, especially in this case where the model is still a work-in-progress. In one of the few VOI analyses conducted for a U.S. population, Hassan and colleagues 52 estimated an EVPI for colorectal cancer screening of $216 per subject, less than 25 percent of the estimated values calculated here. One obvious next step after further model refinement is to estimate the population EVPI, which is a function of the expected number of patients affected, the expected duration of use of a given treatment or treatments, and the societal discount rate. 58 In the 2007 Nationwide Inpatient Sample, there were approximately 250,000 admissions with procedures performed for a primary diagnosis of uterine fibroids, 1 which, given the increasing use of outpatient treatments, is likely an underestimate of the potential population. Assuming another 20 percent of cases done as outpatients (approximately 300,000 patients annually) and a 3 percent annual discount rate, the population EVPI based on our preliminary results ranges from $1.5 billion over 5 years at a willingness-to-pay threshold of $50,000/QALY to $3.8 billion over 10 years at a threshold of $100,000/QALY (the comparable 5-year population EVPI for colorectal cancer screening, which affects approximately 15 million people annually, was $15 billion 52 ).

Specific areas for further model refinement include:

• Incorporating uncertainty about relative treatment effects on reproductive outcomes.
• Incorporating the effect of natural menopause, as well as any interactions between treatment and declining ovarian function.
• More precise delineation of parameter distributions through collaborations with researchers with appropriately large datasets.
• Estimation of population-level EVPI for subpopulations and EVPPI for model parameters.

The results of our VOI analysis, in terms of ranking of areas of uncertainty, were concordant with the areas of highest priority identified through the modified Delphi process used by the Outcome/CMTP group to develop a research agenda for comparative effectiveness research for fibroid management. It is possible that this agreement is at least partially due to decisions made about the scope and structure of the analysis in order to facilitate this specific comparative project, and comparison of these results to those from a more fully developed model is in order. We also emphasize, as noted above, that the actual differences between specific EVPPIs are quite similar, and it is possible the relative ranking might change with additional model refinement. Despite these and the other limitations discussed above, the stakeholders who reviewed these results felt that VOI analysis had the potential to be a valuable part of any research priority-setting process, primarily either as background or in parallel with a more traditional consensus-based approach.

We discuss the potential implications of these results for incorporation of VOI into future research needs assessments, along with suggestions for further methodology development, in the next section.

• Cite this Page Myers E, Sanders GD, Ravi D, et al. Evaluating the Potential Use of Modeling and Value-of-Information Analysis for Future Research Prioritization Within the Evidence-Based Practice Center Program [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2011 Jun. (Methods Future Research Needs Reports, No. 5.) Case Study: Uterine Fibroids.
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