Dr. Sharda Jain
* Consultant Gyanecologist, Pushpanjali Medical Centre
* Secretary General .Delhi Gyanecolgist Forum
“World over it is now discussed that global Endometrial Ablation Techniques should be tried as an alternative to hysterectomies”.
Dysfunctional uterine bleeding (DUB) is a common gynaecological disorder.
If affects 1 in 5 women.
One in 20 women aged 30- 49 years, consult a doctor with a history of excessive bleeding and surgical intervention.
One in five women in the UK with present trends, need a hysterectomy before the age of 60 years, and 1:3 women in USA will have hysterectomy .
It is a well known fact that in at least 50% of those who have undergone hysterectomies, menorrhagia is the main presenting problem. About half of all women (50%) who have had a hysterectomy for menorrhagia, have a normal uterus removed!.
DUB describes the spectrum of abnormal menstrual patterns that may occur in ovulatory and anovulatory women who have had no medical illness or pelvic pathology. Anovulatory bleeding can be managed with “Medical treatment” based on sound physiologic concepts . The goal of medical management of Anovulatory DUB is to reverse the abnormalities of endometrial growth and development associated with chronic anovulation and to induce and restore cycle and predictable menses. However it is effective in 20-30% cases only.
Ovulatory DUB is most common in parous women age 30-45 years . it is associated with a series of vascular and haemostatic disturbances which contribute to increased loss of blood at menstruation. Medical treatment invariably is not effective in this group.
In recent years, a number of new surgical techniques that aim to destroy the endometrium have been developed.
Hystereocopic endometrial resection has been there since 1983. But alternatives were sought due to the difficulty in perfecting the techniques, the risks of fluid overload associated with the use of glycine and the higher incidence of complications by poorly trained doctors.
Millions of global ablation cases have been performed world wide without the use of hysteroscopy . With a view to simplifying and expediting the procedure of endometrial resection, the Uterine Balloon Therapy (UBT) procedure was introduced by Neuwirth in 1994.
For newer ablation therapies, it is essential that strict criteria for patient selection are implemented. These include.
- Assessment of patient expectations.
- Desire to conserve uterus.
- Absence of anatomical abnormalities in the uterus including polyps and fibroids.
- Uterine cavity depth not greater than 10-12 cm
- Exclusion of cervical and uterine malignancy
- Absence of previous uterine surgery.
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Thermachoice UBT consists of a 16 cm long and 4.5 mm wide catheter with a latex balloon at its distal end, which houses the heater element. The catheter is connected to a control unit that monitors, displays and controls pre-set intra-uterine balloon pressure, temperature and duration of treatment. After the balloon catheter insertion, sterile 5% dextrose is injected into the balloon until the intra-uterine pressure stabilizes between 160 and 180 mm Hg. The fluid within the balloon is heated to approximately 87o C and the treatment automatically continues at that temperature for 8 min. For safety, the device automatically deactivates if the pressure or the temperature fluctuates below or above preset values.
Thermachoice UBT is a much simpler technique. It is easy to learn; and does not require an elaborate set-up as one requires for hysteroscopic ablation technique. The complications are hardly any compared to the traditional ablation therapy using Yag laser or resectoscope.
More than 100,000 women have been treated world wide with UBT without using any additional medical treatment. More than 95% of patients have remained satisfied with treatment at the 3 year follow-up.
The ease of use, patient tolerance, demonstrated safety profile and comparable efficacy of non-hysteroscopic endometrial ablation using Theramachoice UBT system provides a good alternative to hysterectomy. The introduction of UBT to treat DUB has significantly reduced the incidence of hysterectomy in USA and in my own practice . |
Among women with excessive bleeding who undergo an endometrial ablation, 80-90% report significantly reduced bleeding, 25-50% develop amenorrhoea, 70-80% report markedly less pain and bleeding , over 90% are satisfied with the outcome.
I have personally performed more than 300 uterine balloon therapies over a period of seven years. The ease of operation, safety of the procedure and the results are remarkable. . It is very patient friendly procedure, though not cheap if new balloon is used.
Endometrial sampling with in 6 months of UBT is mandatory. We liberally used Injection Depoprovera post operatively at 3 monthly interval for first two years in perimenopasual patients , both for contraception and procure amenorrhea state. 63% of our patients had amenorrhoea. This was significantly more in cases after the age of 45 years.
No patient required hysterectomy so far . One patient ( aged 53 years, Principal, College of Delhi University) opted for repeat Balloon Therapy for post menopausal spotting instead of hysterectomy after 4 years of initial balloon therapy . The satisfaction level is almost 100%. The reason of very good results in my practice are strict criteria of patient selection and use of injection Depoprovera. Twenty seven patients with 1 or 2 cesarean section were not excluded in my series of UBT. It is a safe technique if proper evaluation is done.
Ablation is usually performed during the early follicular phase and after the endometrium is first attenuated for 4-6 weeks prior to ablation using progestin, danazol or GbRh-a. In my practice, we have not used any such agents for endometrial priming. Eighteen patient had haemoglobin less than 5 gm%. |
Thermachoice for high risk patients
This procedure is simply a boon for treatment of Heavy bleeding in high risk patients for surgery, such as those with morbid obesity, multiple previous abdominal surgeries, heart, lung or renal disease patients and those with bleeding disorders etc. Since this can be done under local anesthesia the risks of general anesthesia are eliminated. Also, the procedure has a minimal complication rate, is simple, fast and ideal for these patients .
In my own practice, 28 cases have been done with 100% satisfactory results at 3-5 years follow up. However, it was made amply clear in counseling session that it is palliative treatment in presence of fibroid seedlings only to control bleeding and follow up is mandatory.
- Renal failure – 3
- Morbid Obesity – 7 (BMI > 40)
- Bleeding disorders- 3
- Leukaemia – 2
- Compromised cardiac status - 13
- LVEF < (30%)
Ten of these patients had heamoglobin of less than 5 gm% as well.
Comparisons and outcome
An RCT conducted by Van Zon Rabelink et al 2 showed that uterine thermal balloon ablation is equally effective as hysteroscopic roller ball ablation of endometrium at the end of 3 years.
Barrington 3 compared UBT to LNG-IUD and concluded that both are equally effective for the treatment of DUB.
Cooley et al4 studied the medium ( 1-3 year ) and long term ( 3-5 year ) outcomes of women who had undergone UBT and found over 90% success rate after three years with out any adjuvant therapy .
Factors which affect success of treatment are:
- Properly chosen cases ( No fibroids, polyps or suspected malignancy).
- Increased age (> 40 years)
- Shorter utero cervical length
- Good balloon pressure during the procedure
Cooper et al 5 studied the safety and effectiveness data from the FDA on Global Ablation Devices and noted that at one year follow up, Thermachoice and Novasure had the highest success rates.
According to Solnik J M et al’s 6 study, 72% of all cases of ablation in a large university hospital were being performed using Thermachoice uterine balloon. At the end of two years, 94% of the women were satisfied with this procedure.
So, today UBT appears to be the chosen method for treatment of DUB. In USA the trend is emerging that few insurance company insist that Global Ablation technique to be tried prior to hysterectomy in cases of DUB. I hope it will be good reading and the benefits of this information are passed on to your patients.
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Gynaecare
Thermachoice |
Hormone
Therapy |
D & C |
Hysterectomy |
| Definitive treatment for the majority of women |
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| Minimally invasive |
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| No overnight stay required |
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| Most patients return to normal activity within 1 week |
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References:
- Neuwirth RS, Ob Gynaecol 1994;83792-796
- Van Zon Rabelink etal ,EUR J Obs Gynaec Biol 2004 May 10;114(1) 97-103
- Barrington Eur J Obs Gynaec Reprod Biol 2003 May1. 108 (1) 72-4
- Cooley etal EUR J Obs Repord Biol 2005 Aug 1; 121(2) 233-5
- Cooper etal J Reprod Med 2004 April, 49 (4) 267-73
- Solink J M etal Am J Obs Gynae 2005 Jul; 193 (1) 98-102
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