Fibromyoma - Standard Treatment Guidelines

Leiomyoma of uterus also called as fibromyoma or fibroid uterus is a benign tumor of uterus, essentially composed of smooth muscle tissue and a variable amount of fibrous connective tissue. It is the most common tumor of uterus , and is found in 20% of women in reproductive age group.

Leiomyomas are the reason behind one third of all hospital admissions to gynecology services and one of the commonest indications for hysterectomy.

Fibroid Uterus is more common among older nulliparous and obese women, particularly the ones with family history of this disease. Based on the location of tumor in the uterus, various types of myoma are subserous, intramural and submucous fibroids.

Ministry of Health and Family Welfare, Government of India has issued the standard Treatment Guidelines for Leiomyoma Uterus/ Fibromyoma/ Fibroid Uterus. Following are the major recommendations:

Incidence of Fibroid In India :

Nearly 20-30% women in reproductive age group have fibroid uterus. At any given time, nearly 15-25 million Indian women have fibroid uterus.

Differental Diagnosis

• Adenomyosis


• Bicornuate uterus


• Ovarian tumor


• Retroperitoneal connective tissue tumor


• Calcified tuberous pyosalpinx

Complications:

• Torsion of pedunculated subserous fibroid


• Infection of submucous myoma


• Ascites may be caused rarely by pedunculated subserous fibroid


• Intraperitoneal hemorrhage from rupture of a large vein on the surface of myoma (rare)


• Malignant change in 0.2% of uterine fibroids


• Degeneration (Hyaline/Cystic/Fatty/Red degeneration) 5


• Pregnancy complications like spontaneous abortion, preterm delivery, abruptionplacentae


• Labor complications: Inertia, Dystocia, PPH

Pelvic pathologies commonly co-existent with fibroid uterus

• Endometrial hyperplasia and endometrial polyps


• Endometriosis


• Anovulation and dysfunctional uterine bleeding


• Pelvic inflammatory disease


• Tubal pregnancy

Optimal Diagnostic Criteria, Investigations, Treatment & Referral Criteria

Situation 1: At Secondary Hospital/ Non-Metro situation: Optimal Standards of Treatment in Situations where technology and resources are limited

Clinical diagnosis:

History

• Most leiomyomas are asymptomatic and are diagnosed incidentally


• Bleeding-Menorrhagia, Meno-metrorrhagia

Continuous/irregular bleeding and blood-tinged discharge per vaginum may occur in cases of surface ulceration of submucosal fibroid polyp.

• Pressure symptoms-Pelvic discomfort or feeling of heaviness in pelvis

-Acute urinary retention

-Urgency or frequency of micturition

-Rarely dyspepsia or constipation

• Pain Dysmenorrhoea

Lower abdominal and pelvic pain: Not a common symptom but may occur in cases of fibroid polyp/ torsion of pedicle of subserous pedunculated fibroid/ degeneration of fibroid/ sarcomatous change in fibroid

• Infertility


• Pregnancy complications-Increase in size with red degeneration, abortions, preterm labor, malpresentations


• Labor complications-Inertia, Dystocia, PPH

Examination

• General physical examination-Pallor may be present in cases of anemia due to menorrhagia.


• Abdominal examination may reveal a firm, non-tender, rounded/lobulated mass with side to side mobility and which is dull to percuss. (Only in cases of huge fibroids)


• P/S exam- Submucosal fibroid polyp may be seen coming out of the cervix into the vagina .with ulceration of surface of mass,seen as white discharge or bleeding.


• P/V-Bimanual pelvic examination reveals an enlarged irregular firm uterus, but it may be symmetrically enlarged in cases of intramural and submucous fibroid. Subserous fibroid may be felt attached to the uterus or it may be felt as irregularity on one side or as an adnexal mass in case it is pedunculated or broad ligament fibroid. Submucosal fibroid polyp may be seen/ felt coming out of the cervix into the vagina.D/D with inversion ut

Investigations

• CBC


• Blood grouping and Rh


• Urine routine and microscopy


• Ultrasonography


• Pap smear


• Endometrial biopsy when diagnosis is in doubt

Treatment

Treatment modality should be individualized to each patient after considering patient's age, severity of symptoms, need for fertility preservation, presence of other gynecological diseases and any other co-morbidity.

• Small Leiomyomas discovered incidentally and not associated with any complications usually do not require any treatment. Performing hysterectomy for an asymptomatic fibroid for the sole purpose of alleviating the concern that it may be malignant is not warranted. Such patients should be explained, reassured and called for examination at periodic intervals.

Asymptomatic fibroid may warrant treatment in following situations:

• The size of fibroid uterus is more than 12-14 weeks pregnant uterus


• Rapidly growing fibroid


• Evidence of hydroureter / hydronephrosis resulting because of compression of ureters by the tumor.


• Subserous pedunculated fibroids are liable to undergo torsion of pedicle and hence may be treated even if asymptomatic.


• General measures: Correction of anemia with hematinics (iron & folic acid). Severe anemics with ongoing blood loss may require packed cell transfusion. Reducing blood loss during periods.

Medical management:

This should be tailored to suit the needs of the woman. However, the costs & side effects of different drugs may limit their long term use. Gonadotropin releasing hormone agonists may be given pre-operatively in order to reduce blood loss and operating time prior to hysterectomy, myomectomy or myolysis.

Indications of GnRH agonists administration:

A) Preoperatively to shrink fibroids and to reduce menstrual related anemia

B) Short term alternative to surgery in perimenopausal females.

C) Tab / Inj)tranexamic acid may reduce menorrhagia associated with fibroids

D) Tab danazol has been associated with reduction in volume of fibroid by 20 -25%. Although long term response to danazol is poor ,it may offer an advantage in reducing menorrhagia

Disadvantages of giving GnRH agonists

E) High cost

F) Side effects like hot flashes & vaginal dryness

G) Risk of development of osteoporosis if given for more than 6 months.

H) Higher risk of recurrence of fibroids after myomectomy if GnRH analogues have been given pre-operatively.

Some other drugs that can be employed along with their indications & side effects are enlisted below:

Treatment	Indications & Potential unwanted outcomes experienced by some women (Common: 1 in 100 chance; less common: 1 in 1000 chance; rare: 1 in 10,000 chance; very rare: 1 in 100,000 chance)
Levonorgestrel-releasing intrauterine system	Small fibroids not distorting the uterine cavity Common: irregular bleeding that may last for over 6 months; hormone-related problems such as breast tenderness, acne or headaches, which, if present, are generally minor and transient Less common: amenorrhoea Rare: uterine perforation at the time of insertion
Tranexamic acid	Menorrhagia Less common: indigestion; diarrhoea; headaches
Non-steroidal anti-inflammatory drugs	Menorrhagia & dysmenorrhea Common: indigestion; diarrhoea Rare: worsening of asthma in sensitive individuals; peptic ulcers with possible bleeding and peritonitis
Oral progestogen (norethisterone)	Size reduction Common: weight gain; bloating; breast tenderness; headaches; acne (but all are usually minor and transient) Rare: depression
Injected progestogen	Size reduction Common: weight gain; irregular bleeding; amenorrhoea; premenstrual-like syndrome (including bloating, fluid retention, breast tenderness) Less common: small loss of bone mineral density, largely recovered when treatment discontinued

Though many gynaecologists are using danazol & mifepristone to reduce the size of the fibroids with good results, there is no definite consensus on their use & further trials are necessary to clearly define their roles.

Surgical treatment

-Hysterectomy is the surgical removal of uterus which may be done abdominally/ vaginally or laparoscopically based on the size of uterus, mobility and descent of uterus, patient's desire and presence of other gynecological diseases and other co-morbidities. In women who don't wish to preserve uterus/ fertility, hysterectomy is a definitive treatment. Disadvantages of hysterectomy are the surgical and anaesthetic risks involved in the same.

-Myomectomy is the surgical removal of myomas while uterus is being preserved. This may be done abdominally/ vaginally/laparoscopically or hysteroscopically, depending on the site and size of myomas. The merit of myomectomy lies in preservation of fertility but the disadvantage is risk of recurrence of fibroids, which may require a repeat surgery. Myomectomy is usually preferred in patients less than 40 years of age, who wish to preserve their menstrual and reproductive functions. Vaginal myomectomy is suitable for patients with submucous pedunculated fibroid projecting into vagina.

Referral criteria

• Patients desirous of fertility & have fibroids that distort the uterine cavity where no other factors have been identified can be managed by laparoscopic / hysteroscopic myomectomy & should be referred to a super specialty hospital, in case facilities for the same are not available in situation.


• Pregnant women may require additional fetal surveillance when the placenta is implanted over or in close proximity to a fibroid.


• In case laparoscopic hysterectomy is planned and adequate facilities / equipment / skilled laparoscopic surgeon / anaesthetist are not available, patient should be referred to a super specialty hospital in a metro location.


• Patients suitable for uterine artery embolization procedure/myolysis


• Presence of co-morbidities like cardiac diseases, pulmonary diseases etc.


• HRT may be given if indicated in postmenopausal women. Although it causes myoma growth in postmenopausal women, it does not appear to cause clinical symptoms. Postmenopausal bleeding and pain in women with fibroid should be investigated in the same way as in women without fibroids.

Situation 2: At Super Specialty Facility in Metro location where higher-end technology is available

Clinical diagnosis:

History

• Most leiomyomas are asymptomatic and are diagnosed incidentally


• Bleeding-Menorrhagia, Meno-metrorrhagia

Continuous/irregular bleeding and blood-tinged discharge per vaginum may occur in cases of surface ulceration of submucosal fibroid polyp.

• Pressure symptoms-Pelvic discomfort or feeling of heaviness in pelvis

-Acute urinary retention

-Urgency or frequency of micturition

-Rarely dyspepsia or constipation

• Pain Dysmenorrhoea

Lower abdominal and pelvic pain: Not a common symptom but may occur in cases of fibroid polyp/ torsion of pedicle of subserous pedunculated fibroid/ degeneration of fibroid/ sarcomatous change in fibroid

• Infertility


• Pregnancy complications-Increase in size with red degeneration, abortions, preterm labor, malpresentations


• Labor complications-Inertia, Dystocia, PPH

Examination

• General physical examination-Pallor may be present in cases of anemia due to menorrhagia.


• Abdominal examination may reveal a firm, non-tender, rounded/lobulated mass with side to side mobility and which is dull to percuss. (Only in cases of huge fibroids)


• P/S exam- Submucosal fibroid polyp may be seen coming out of the cervix into the vagina .with ulceration of surface of mass,seen as white discharge or bleeding.


• P/V-Bimanual pelvic examination reveals an enlarged irregular firm uterus, but it may be symmetrically enlarged in cases of intramural and submucous fibroid. Subserous fibroid may be felt attached to the uterus or it may be felt as irregularity on one side or as an adnexal mass in case it is pedunculated or broad ligament fibroid. Submucosal fibroid polyp may be seen/ felt coming out of the cervix into the vagina.D/D with inversion ut

Investigations

-CBC

-Blood grouping

-Urine routine and microscopy

- Ultrasonography (Transabdominal & transvaginal)

-Sonohysterography /Hysteroscopy

- Pap smear

- Endometrial biopsy where indicated.

-Magnetic resonance imaging (if needed)

Treatment

Treatment modality should be individualized to each patient after considering patient's age, severity of symptoms, need for fertility preservation, presence of other gynecological diseases and any other co-morbidity. Management of asymptomatic fibroids, general measures and medical management as already mentioned in situation.

Surgical treatment

Options are as already mentioned in situation. Laparoscopic hysterectomy or laparoscopic myomectomy can be offered in case where patient does not have any cardiac or respiratory disorders which contradict the same. Very large tumors may limit the suitability of the case for laparoscopic management. Subserous pedunculated fibroids are usually good candidates for laparoscopic myomectomy. Hysteroscopic myomectomy can be done for symptomatic submucosal fibroids.

-Laparoscopic Myolysis or myoma coagulation is usually done with Nd:YAG lasers or bipolar needles. This results in necrosis and shrinkage of myoma. It may be combined with endometrial ablation to reduce bleeding. Women may be candidates for myolysis if they have fewer than four myomas of ≤ 5 cm or if their largest myoma measures less than 10 cm in diameter. Laproscopic myolysis may present an alternative to myomectomy or hysterectomy for selected women with symptomatic intramural or subserous fibroids who wish to preserve their uterus but do not desire future fertility( sogc level II b )

Non-surgical treatment:

-Uterine artery embolization is an interventional radiologic procedure to occlude uterine arteries and hence relieves menorrhagia in more than 90% of patients. In this procedure, a micro-catheter is introduced into the uterine artery via femoral approach and usually polyvinyl alcohol foam particles are used to occlude uterine arteries. This results in infarction of myomas. It has the advantage of being a minimally invasive procedure, avoids surgery and entails a shorter duration of hospital stay. Its role in preservation of fertility is yet undetermined pending long term studies. The disadvantage is risk of symptom recurrence in nearly 17% cases.

Magnetic-resonance-guided focused ultrasound surgery:

Magnetic-resonance-guided focused ultrasound surgery (MRgFUS) is a non-invasive thermo-ablative technique that uses focused high-energy ultrasound to ablate fibroid tissue. As in conventional diagnostic ultrasound, the ultrasound waves pass through the anterior abdominal wall. Significant heating only occurs where the waves converge at the focus. Magnetic resonance guidance provides continuous imaging of the fibroid and other vital structures such as bowel, bladder and sacral nerves.

Significant improvement in quality-of-life parameters has been reported in women undergoing MRgFUS. Given considerable symptoms at enrolment and a large decrease in mean symptom levels, this appears to be a clinically significant result. The volume reduction after treatment is small compared with the mean levels seen after both myomectomy and uterine artery embolization (UAE). MRgFUS appears to be a safe intervention for uterine fibroids.

Furthermore, women who have treatment with MRgFUS do not appear to develop symptoms similar to the postembolization syndrome symptoms associated with UAE.

However, the true place of MRgFUS is yet to be established in comparison with the other available treatment modalities by way of randomized controlled clinical trials.

Guidelines by The Ministry of Health and Family Welfare :

Dr Ashley J D'cruz Narayana Hrudyalya Hospital. Bangalore

Dr. Garima Arora Gandhi & Dr. Lavanya.R Department of Obstetrics and Gynaecology Narayana Hrudyalya Hospital. Bangalore

Dr. Sharath Damodhar ( HOD, Dept. of Haemotology), Narayana Hrudayalaya Karnataka,

Dr.Basavaraju Narasimhaiah, DGO, Tumkur Government Hospital, Karnataka,