Study Objective. To determine the location and depth of uterine arteries from the vaginal fornix using a Doppler-guided non-incisional 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.

OBJECTIVE:To provide an overview of the approved second-generation endometrial ablation technologies.STUDY DESIGN:Data from the FDA Summary of Safety and Effectiveness Data were compared for Thermachoice, HydroThermablator, Her Option and Novasure devices.RESULTS:At 12 months' follow-up, Novasure and HydroThermablator had the highest amenorrhea rates. Thermochoice and Novasure had the highest success rates at 12 months. Novasure had the lowest adverse event rates in the first 24 hours, between 24 hours and 2 weeks and between 2 weeks and 1 year of follow-up.CONCLUSION:Summary of Safety and Effectiveness Data, obtainable on the FDA Web site, offers objective data for comparing second-generation endometrial ablation technologies.

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.

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.

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.

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.

OBJECTIVE: To assess the safety, effectiveness, and reliability of a tribal 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. Uhimately, 449 of 518 women (87%) could rely on the micro-insert 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.

I feel honored and fortunate to have been given the opportunity to serve as president of the AAGL. The support and encouragement offered to me by my fellow Board members, Executive Committee, and the membership at large have been exceptional and greatly appreciated. Three years ago the Nominating Committee of the AAGL graciously asked me to become the organization’s first president of the new millennium. Because of family and professional concerns, I had previously declined two earlier invitations, but this time I willingly accepted their offer. It was an easy decision for me to make. The AAGL had grown into a large, wellrespected, and stable professional organization. Its governance was in the excellent hands of Dr. Jordan Phillips, founder and chairman of the Board, and a strong, hard-working Board of Trustees. Having previously served on the Board, I understood well the inner workings of the association, and I would be following two very strong and capable presidents, Drs. Victor Gomel and Bill Parker. I was now in my midfifties, my children were grown, my medical practice was well established, and, looking into the mirror, I realized I had just the right amount of gray hair to be a credible president of the AAGL. Traditionally, the most challenging year for an officer of the AAGL is that served as vice president, during which time one is primarily responsible for designing and organizing the annual meeting. Last fall, as I was putting the finishing touches on the scientific program for the meeting to be held in Orlando, I allowed myself the luxury of looking ahead to the coming year, the year in which I would assume the role of president. I had been reassured by several past officers that that year would be a piece of cake—one of calm and relaxation. A few days later, and only 6 weeks before the annual meeting was due to convene, I received a call from Dr. Phillips informing me, as he had others on the Executive Committee, of his decision to step down from his role as chairman of the Board. As the shock of this conversation slowly wore off, I wondered,

Study Objective. To compare the safety and effectiveness of the NovaSure impedance-controlled endometrial ablation system with hysteroscopic wire loop resection plus rollerball ablation for treatment of excessive uterine bleeding in premenopausal women.Design. Randomized, multicenter, double-arm study (Canadian Task Force classification 1).Setting. Nine academic medical centers and private offices.Patients. Two hundred sixty-five premenopausal women with symptomatic menorrhagia.Intervention. Ablation performed with the NovaSure system or wire loop resection and rollerball.Measurements and Main Results. Success [pictorial blood loss-assessment chart (PBLAC) score 5751 was achieved in 88.3% of NovaSure-treated and 81.7% of rollerball-treated patients. One year after treatment 90.9% and 87.8%, respectively, reported normal bleeding or less (PBLAC less than or equal to 100) and 41% and 35%, respectively, experienced amenorrhea (PBLAC = 0). Mean procedure time was 4.2 minutes (average 84 sec) in the NovaSure group and 24.2 minutes in the rollerball group. Local and/or intravenous sedation was administered in 73% of NovaSure patients and 18% of rollerball patients. Intraoperative adverse events occurred less frequently with NovaSure (0.6%) than with rollerball (6.7%). Postoperative adverse events occurred in 13% and 25.3% of patients, respectively.Conclusion. The NovaSure system was safe and effective in treatment of women with menorrhagia. The procedure is both quick and effective, and eliminates the expense and side effects of endometrial pretreatment.

The objective of this paper was to determine the safety effectiveness and tolerance of a new transcervical fallopian tube permanent contraception device the Essure microinsert. In a previous study histology of fallopian tubes of women who had worn the device for periods of 5-15 weeks demonstrated that the device was benignly incorporated into the fallopian tubes with a localized tissue reaction. Enrolled women requesting permanent contraception underwent hysteroscopic sterilization with Essure microinserts. Following successful device placement the women were instructed to use alternative contraception for 3 months after device placement and to have hysterosalpingography performed prior to discontinuing alternative contraception. Study subjects were seen at outpatient surgical facilities and physicians offices at investigational sites. Their ages ranged from 21-45 years and they had documented fertility. Hysteroscopy-directed placement of the Essure microinserts was performed under local anesthesia or analgesia or both. Of the 871 women who were involved 745 (85%) women were attempted. 603 out of 627 (96.2%) women with satisfactorily placed microinserts had bilateral occlusion at 3 months; 625 (99.5%) had bilateral occlusion at 6 months. 193 women have been relying on the Essure microinsert for more than a year. No pregnancies have occurred. The procedure was well tolerated by over 90% of the women; it averaged 13-18 minutes and resulted in tolerable or no postoperative discomfort. Local anesthesia and intravenous sedation were the anesthesia used for 92.9% of the patients. Favorable clinical results and marked patient satisfaction have been noted in this investigational study. Preliminary results suggest that the hysteroscopic tubal sterilization method with the Essure system offers promise as an alternative to presently used methods of permanent contraception. (authors)

Women's Health Research, Phoenix, AZ *This document includes a discussion of use of a product that is unapproved by the U.S. Food and Drug Administration.

ObjectiveTo assess and compare the efficacy of NovaSure, a novel 3‐D bipolar endometrial ablation system, for women with severe menorrhagia secondary to dysfunctional uterine bleeding (DUB), with and without endometrial preparation.Study designA prospective, double‐arm, controlled, observational pilot study of 40 women undergoing endometrial ablation using the NovaSure system.Patients40 premenopausal women, of average age 44 years, with menorrhagia secondary to DUB and unresponsive to medical therapy, who had completed childbearing, with non‐distorted uterine cavities, and cornu‐to‐cornu measurement of greater than 2.5 cm.InterventionsEndometrial ablation using the 3‐D bipolar NovaSure system.Methods50% of the patients received gonadotrophin‐releasing hormone (GnRH) agonist for endometrial thinning. The remaining patients received no treatment for endometrial thinning. Pictorial blood assessment chart (PBLAC) diary sampling was used to select patients for the study, as well as to conduct the post‐treatment evaluation of menstrual blood loss and bleeding pattern (amenorrhoea, spotting, hypomenorrhea, eumenorrhoea or menorrhagia). All patients received the treatment under intravenous sedation with paracervical block.ResultsNo intraoperative complications were observed. Treatment time averaged 72 seconds. Follow up of 12 months has been completed in 29 patients. No significant difference was observed in the outcome (i.e. efficacy) of the procedure between the two groups of patients.ConclusionsPreliminary results indicate that the NovaSure system can be successfully used as an effective method of treatment for women with menorrhagia secondary to DUB. Endometrial pretreatment appears not to be necessary in global ablation performed using the NovaSure system.

There have been many advances in sampling of the endometrium. Ideas and technologies have evolved, increasing our ability to gather adequate specimens that provide reliable information about uterine cavity pathologies. No technique surpasses the sensitivity and specificity of hysteroscopy with directed biopsy. Owing to its superior diagnostic potential, hysteroscopy, even when performed in the office with narrow scopes (not significantly larger in diameter than the Pipelle catheter), leads to precise diagnosis and appropriate management of intrauterine pathologic conditions. For physicians who are untrained or lacking the equipment to perform diagnostic hysteroscopy with directed biopsy, simple in-office endometrial sampling techniques with no visual control provide a means to obtain reasonably reliable samples with negligible patient discomfort.

Study Objective. To compare a distensible multielectrode balloon for endometrial ablation with electrosurgical ablation performed by a combined resection-coagulation technique.Design. Randomized prospective trial (Canadian Task Force classification 1).Setting. Eight centers.Patients. Women with menorrhagia validated with a standardized pictorial blood loss assessment chart (PBAC), without intracavitary organic uterine disease, who failed or poorly tolerated medical therapy.Intervention. Results in 122 patients treated by Vesta and 112 treated surgically, evaluable at 1 year, were compared, with success defined as monthly blood loss of less than 80 ml and avoidance of additional therapy.Measurements and Main Results. Pretreatment PBAC scores for patients treated by Vesta and resection or roller-ball were 535 +/- 612 and 445 +/- 313, respectively; at 1 year they were 18 +/- 37 and 28 +/- 60, respectively. With PBAC below 75 as the definition of success, 86.9% of Vesta-treated patients were successful compared with 83.0% treated by rollerball or resection. Total amenorrhea, defined as no visible bleeding and no use of protective products, was 31.1% and 34.8%, respectively. None of the outcome comparisons between treatments showed statistical difference. Complications in both groups were few and minor. Most(86.6%) Vesta procedures were carried out with paracervical block with or without intra venous sedation in an office or outpatient setting, compared with 79.7% epidural or general anesthesia for rollerball or resection.Conclusion. The Vesta system of endometrial ablation is equally effective and safe as classic resectoscopic methods. Potential advantages include avoidance of fluid and electrolyte disturbance associated with intravasation of distending media, and ability to perform the procedure under local anesthesia in an office setting with less total operating time.