Safe alternative to hysterectomy for abnormal uterine bleeding – Uterine Balloon Therapy
Menorrhagia is a common problem affecting women in the age group 35-45 years.Technically, menorrhagia is defined as heavy periods lasting longer than 7 days, or a blood loss more than 60- 80 ml (4 – 5 tablespoons approximately) or presence of clots or when there is a chance of staining clothes. Heavy periods are not just an embarrassment , but they can seriously disturb a woman’s lifestyle , cause anaemia , ill-health and low morale .
The most common cause of heavy periods before menopause is hormonal imbalance , seen in 40% of patients . Other causes include benign growths (fibroids, polyps) , cancer and precancer conditions of uterus , infections , medical disorders of blood , liver , kidneys , or the use of certain drugs like anticoagulants , steroids , and chemotherapy .
Traditionally , the first line of therapy in women with no obvious or detectable cause of abnormal bleeding (dysfunctional uterine bleeding – DUB) is medical. The drugs include estrogens , progestins , Danazol , GnRHanalogues , antiprostaglandins like Mefenamic acid , Ibuprofen , antifibrinolytics like Tranexamic acid and SERMS like Orniloxifene . These remedies have their own side-effects and contraindications . They need to be given repeatedly over long periods of time. Symptoms of heavy bleeding usually return once medication is stopped . They are less effective than surgical measures and can decrease blood flow in only 25-80 % of cases and other than GnRHa cannot stop the bleeding altogether . Drugs are often prescribed for women who desire future childbearing .
Dilatation and Curettage (D & C) is not really considered as a treatment of heavy bleeding because only the top layer of the lining of the uterus is removed . It provides only temporary relief for , at most , few cycles or no relief at all . D&C is mainly for diagnosis for which too it is not a very effective because it can miss fibroids or polyps since it is a blind procedure .
Surgical options for the treatment of DUB include hysterectomy (removal of uterus) and 2 different forms of endometrial ablation (destroying the lining of the uterus from where the bleeding actually occurs) .
In the United States alone , around 600,000 hysterectomies are performed every year of which 50% are for abnormal uterine bleeding . Around 100,000 of these uterus specimens do not show any cause for the abnormal bleeding on histology . Most of the patients who do not respond to medical therapy , or are unable to tolerate it or unwilling to try it will undergo hysterectomy as the final answer . Even though it cures , hysterectomy is not a trivial undertaking . The surgery itself has a mortality of 6-11 per 10,000 procedures and a complication or morbidity rate of 3-50% either due to the operation itself or due to the anaesthesia . It requires several days of hospitalization and at least 6 weeks for complete recovery . Safer alternatives to hysterectomy are the ablation procedures which do not involve removal of an organ , the uterus . Hysterectomy should only be considered in patients who fail to respond to ablation or are not candidates for ablation .
With the boom in minimally invasive surgical techniques in the 80’s , hysteroscopic Trans Cervical Resection of the Endometrium (TCRE) was the choice of treatment for patients who wanted to avoid hysterectomy . Under direct view of the endoscope in the uterus (hysteroscope) the lining of the uterus is destroyed with an electrosurgical loop or roller ball or laser . Although other hysteroscopic operative procedures are highly successful , TCRE is associated with a mortality rate of 0.02 % and serious complications in upto 7% of patients like heart failure due to fluid overload , bleeding , infections or perforations .
To overcome the disadvantages and risks of established treatments , less invasive and patient friendly procedures were developed like the Uterine Balloon Therapy (THERMACHOICE) , which has been in use worldwide since several years . Using heat energy upto 87 degrees C for 8 minutes , the lining of the uterus is effectively destroyed upto a depth of 3-7 mm which is enough to decrease or stop heavy bleeding without any major risk .
The Thermachoice Uterine Balloon Therapy system consists of a 4.5 mm diameter catheter with a latex balloon at one end which houses a heating element. The control unit automatically monitors , displays and controls the preset pressure and temperature inside the balloon and the duration of treatment . For safety, the device automatically deactivates when pressure rises or falls below a particular set limit .
Success of any procedure is determined by the results , complication rates, safety and hospitalization . Uterine Balloon Therapy ablation is as good as TCRE , with heavy periods becoming normal or less in about 90% of the cases , with better results in older patients . Failure to decrease heavy bleeding is seen in 7-10% patients especially those with very large uterus . It is extremely safe , with minor complications in 3% patients like fever , pain , infection which respond well to simple measures .
Uterine Balloon Therapy has been approved by FDA (Food and Drugs Administration) , is well tolerated under sedation and local anaesthesia without general anaesthesia , requires only day care hospitalization for 4-5 hours with fast recovery and return to normal activity in 2 days . This procedure can even be done in those patients with certain medical or surgical disorders in whom hysterectomy may be risky or hazardous .
Thus Uterine Balloon Therapy (Thermachoice) has several advantages over hysterectomy, other surgical ablative procedures as well as medical treatments . It is well worth a try in patients of abnormal uterine bleeding with no obvious cause for the bleeding other than hormonal imbalance and when patient does not want any future pregnancy . Hysterectomy should be the last resort in these patients . By this approach many unnecessary hysterectomies can be avoided with considerable benefit to the patients .