Microwave endometrial ablation vs. rollerball electroablation for menorrhagia: a multicenter randomized trial.

STUDY OBJECTIVE: To compare the effectiveness, safety, and acceptability of microwave endometrial ablation (MEA) with those of rollerball electroablation (REA) for the treatment of menorrhagia. DESIGN: Randomized clinical trial (Canadian Task Force classification I). SETTING: Eight academic medical centers and private medical practices. PATIENTS: Three hundred twenty-two women with documented menorrhagia due to benign causes. INTERVENTION: MEA or REA. MEASUREMENTS AND MAIN RESULTS: By intent-to-treat analysis, the success rate of MEA at 12 months (87.0%; CI 81.7%-91.2%) did not differ significantly (p = .40) from that of REA (83.2%; CI 74.7%-89.7%). Among evaluable patients, success rate was also similar (p = .24) in the MEA (96.4%; CI 92.7%-98.5%) and REA (92.7%; CI 85.6%-97%) groups. The amenorrhea rate in evaluable patients after MEA was 61.3% (CI 54.1 %-68.2%). In patients with myomas, the success and amenorrhea rates in evaluable patients after MEA were 90.3% (CI 74.2%-98%) and 61.3% (CI 42.2%-78.2%), respectively. In evaluable patients with body mass index of 30 kg/m2 or greater, MEA success rate was 96.7% (CI 88.5%-99.6%) compared with 81.8% (CI 59.7%-94.8%) for REA (p = .042). The ablation procedure was performed under IV sedation in 62% of patients in the MEA group versus 18% of patients in the REA group (p <.001); whereas, general anesthesia was employed more often in patients undergoing REA (37% vs. 76%, p <.001). No major complications were encountered. Patient satisfaction with results of treatment was high (98.5% of the MEA and 99.0% of the REA group). CONCLUSIONS: Microwave endometrial ablation is an efficacious and safe procedure for the treatment of menorrhagia. Over half of patients treated with MEA achieve amenorrhea, and the procedure is suitable for women with myomas and irregular uterine cavities. The procedure is easily learned and can be performed rapidly, under IV sedation in most cases.

Outcome of uterine embolization and hysterectomy for leiomyomas: results of a multicenter study.

OBJECTIVE: The purpose of this study was to estimate the outcomes of uterine embolization and hysterectomy for uterine leiomyomas. Study design This was a multicenter prospective study of patients who were treated with embolization (n=102 patients) and hysterectomy (n=50 patients) for leiomyomas. Changes in symptoms, complications, and quality of life were measured. The data analysis included linear and logistic regression, the Student t and paired t test, Fisher's exact test, and chi-squared test. RESULTS: For patients who underwent embolization, there were marked reductions in blood loss scores (P <.001) and menorrhagia questionnaire scores (P <.001) compared with baseline. At 12 months, a larger proportion of the patients who had undergone hysterectomy experienced improved pelvic pain (P=.021). Both groups had marked improvement in other symptoms and quality of life scores, with no difference between groups. Complications were more frequent in patients who underwent hysterectomy (50% vs 27.5%; P=.01). CONCLUSION: Both procedures substantially improved symptoms for most patients, with an advantage for hysterectomy at 12 months for pelvic pain. Serious complications were infrequent in both groups.

A nonincisional, Doppler-guided transvaginal approach to uterine artery identification and control of uterine perfusion.

STUDY OBJECTIVE: To determine the location and depth of uterine arteries from the vaginal fornix using a Doppler-guided nonincisional transvaginal approach. DESIGN: Observational study (Canadian Task Force classification II-3). SETTING: Two women's health and fertility centers. PATIENTS: One hundred nine healthy premenopausal women (age >18 yrs). INTERVENTION: Transvaginal uterine artery identification. MEASUREMENTS AND MAIN RESULTS: After uterine size and position were determined, with a standard bivalve speculum in place, uterine arteries were located bilaterally using the DWL Multi-Dop B+ system with 8-MHz probe (Sipplingen, Germany) in toggle mode. Continuous Doppler mode was used to locate uterine arteries, and pulsed Doppler to estimate depth of the arteries from the vaginal fornix. The average uterine size was less than 8 weeks, with the largest measuring 18 weeks' gestational size. The right uterine artery could be identified between 8 and 11 o'clock positions, and was most commonly found at the 9 o'clock position (average depth 9.30 mm, range 4-17 mm). The left uterine artery could be identified between 1 and 4 o'clock positions and was most commonly found at the 3 o'clock position (average depth 8.88 mm, range 4-15 mm). CONCLUSION: Due to ease of identification of uterine arteries transvaginally, despite differences in parity, uterine size, and position, access to and occlusion of uterine arteries with a Doppler-guided device might offer an alternative to invasive procedures intended to occlude uterine artery blood flow in women with symptomatic uterine leiomyomas.

Microinsert nonincisional hysteroscopic sterilization.

OBJECTIVE: To assess the safety, effectiveness, and reliability of a tubal occlusion microinsert for permanent contraception, as well as to document patient recovery from the placement procedure and overall patient satisfaction. METHODS: A cohort of 518 previously fertile women seeking sterilization participated in this prospective, phase III, international, multicenter trial. Microinsert placement was attempted in 507 women. Microinserts were placed bilaterally into the proximal fallopian tube lumens under hysteroscopic visualization in outpatient procedures. RESULTS: Bilateral placement of the microinsert was achieved in 464 (92%) of 507 women. The most common reasons for failure to achieve satisfactory placement were tubal obstruction and stenosis or difficult access to the proximal tubal lumen. More than half of the women rated the average pain during the procedure as either mild or none, and 88% rated tolerance of device placement procedure as good to excellent. Average time to discharge was 80 minutes. Sixty percent of women returned to normal function within 1 day or less, and 92% missed 1 day or less of work. Three months after placement, correct microinsert placement and tubal occlusion were confirmed in 96% and 92% of cases, respectively. Comfort was rated as good to excellent by 99% of women at all follow-up visits. Ultimately, 449 of 518 women (87%) could rely on the microinsert for permanent contraception. After 9620 woman-months of exposure to intercourse, no pregnancies have been recorded. CONCLUSION: This study demonstrates that hysteroscopic interval tubal sterilization with microinserts is well tolerated and results in rapid recovery, high patient satisfaction, and effective permanent contraception.

Hysteroscopic sterilization using a micro-insert device: results of a multicentre Phase II study.

BACKGROUND: Unlike laparoscopic surgery for interval tubal sterilization, a hysteroscopic approach obviates surgical incision and requires only local anaesthesia or intravenous sedation. The safety, tolerability and efficacy of an hysteroscopically placed micro-insert device was evaluated. METHODS: A cohort of 227 previously fertile women participated in this prospective international multicentre trial. Micro-inserts were placed bilaterally into the proximal Fallopian tube lumens under hysteroscopic visualization in outpatient procedures. RESULTS: Successful bilateral micro-insert placement was achieved in 88% of women. The majority of women reported that intraprocedural pain was less than or equal to that expected, and 90% rated tolerance of the device placement procedure as good to excellent. Most women could be discharged in an ambulatory state within 1-2 h. Adverse events occurred in 7% of the women, but none was serious. Correct device placement was confirmed in 97% of cases at 3 months. Over 24 months follow-up, 98% of study participants rated their tolerance of the micro-insert as very good to excellent. After 6015 woman-months of exposure to intercourse, no pregnancies have been recorded. CONCLUSIONS: Hysteroscopic sterilization resulted in rapid patient recovery without unacceptable post-procedure pain, as well as high long-term patient tolerability, satisfaction and effective permanent contraception.

Transvaginal radio frequency treatment of the endopelvic fascia: a prospective evaluation for the treatment of genuine stress urinary incontinence.

PURPOSE: We evaluate the safety and efficacy of a new treatment modality for genuine stress urinary incontinence which was a transvaginal radio frequency applicator to deliver radio frequency energy to the endopelvic fascia. The purported mechanism of effect for this therapy is shrinkage of the collagenated tissue which composes the endopelvic fascia that supports the bladder neck and proximal urethra, thus stabilizing the proximal urethra and bladder neck. In prior animal trials and early pilot studies this therapy was shown to cause a reproducible thermal effect manifested by fascial shrinkage. Preliminary human trials indicated a therapeutic benefit of this therapy for women with genuine stress urinary incontinence. MATERIALS AND METHODS: To our knowledge this is the first multicenter study of a transvaginal approach for radio frequency of the endopelvic fascia for treatment of genuine stress incontinence. Between June 1999 and June 2000, 120 consecutive women (mean age 49.9 years) at 10 sites underwent transvaginal radio frequency treatment in a prospective trial to evaluate the overall efficacy and safety profile of this therapy. All patients had preoperative urethral hypermobility (average cotton swab change 38 degrees). Detrusor instability was excluded by cystometry. In all procedures precisely controlled radio frequency energy was applied to the endopelvic fascia to heat and shrink the tissue. The patients were evaluated postoperatively at 1 week and at 1, 3, 6 and 12 months using objective and subjective measures. Primary end points consisted of physician assessment of continence, patient reported pad use and the number of patient reported episodes. Safety was determined for acute (immediate postoperative) and chronic time frames. RESULTS: Of the 120 patients 96 completed 1-year evaluation. Average operative time was less than 30 minutes, and all patients were treated as outpatients. Preoperatively 101 patients (84%) averaged 1 or more episodes of urinary incontinence per day. At 3, 6 and 12 months 57%, 66% and 59% of patients, respectively, averaged 1 or no daily episodes of urinary incontinence. At 12-month followup 79 of 109 patients (73%) reported being continent or improved. Preoperatively, 43% of patients reported using 1 or no pads daily. At 3, 6 and 12 months 69%, 70% and 72% of patients, respectively, required 1 or no pads daily. On urodynamic evaluation at 12-month followup 76.0% of the patients did not leak with a Valsalva maneuver. A total of 30 cases were classified as failures and 11 women were lost to followup. There were no intraoperative complications, 3 (4%) minor postoperative complications which resolved, and no device related complications. CONCLUSIONS: The transvaginal radio frequency applicator demonstrated good efficacy and excellent safety at 1-year followup. Ongoing analysis of the data has indicated opportunities for improvement of this new surgical technique that could result in higher efficacy rates without compromising safety. Further long-term evaluation is being conducted to assess chronic durability of the procedure.