A Randomized Controlled Multicenter US Food and Drug Administration Trial of the Safety and Efficacy of the Minerva Endometrial Ablation System: One-Year Follow-Up Results.

STUDY OBJECTIVE: To assess the safety and effectiveness of the Minerva Endometrial Ablation System for the treatment of heavy menstrual bleeding in premenopausal women. DESIGN: Multicenter, randomized, controlled, international study (Canadian Task Force classification I). SETTING: Thirteen academic and private medical centers. PATIENTS: Premenopausal women (n = 153) suffering from heavy menstrual bleeding (PALM-COEIN: E, O). INTERVENTION: Patients were treated using the Minerva Endometrial Ablation System or rollerball ablation. MEASUREMENTS AND MAIN RESULTS: At 1-year post-treatment, study success (alkaline hematin ≤80 mL) was observed in 93.1% of Minerva subjects and 80.4% of rollerball subjects with amenorrhea reported by 71.6% and 49% of subjects, respectively. The mean procedure times were 3.1 minutes for Minerva and 17.2 minutes for rollerball. There were no intraoperative adverse events and/or complications reported. CONCLUSION: The results of this multicenter randomized controlled trial demonstrate that at the 12-month follow-up, the Minerva procedure produces statistically significantly higher rates of success, amenorrhea, and patient satisfaction as well as a shorter procedure time when compared with the historic criterion standard of rollerball ablation. Safety results were excellent and similar for both procedures.

Abnormal Uterine Bleeding Control by Sequential Application of Hysteroscopic Lesion Morcellation and Endometrial Ablation.

Objective: To assess the efficacy and safety of combined hysteroscopic morcellation/endometrial ablation for treating abnormal uterine bleeding (AUB). Study Design: Prospective case series from 5 U.S. gynecology clinics. Women with intrauterine polyps and/or type-0 myomas and transformed Uterine Fibroid Symptom and Health-Related Quality-of-Life (UFS-HRQoL) symptom severity score ≥47 points (100 possible) underwent hysteroscopic morcellation (MyoSure) of intrauterine pathologies before endometrial radiofrequency ablation (NovaSure). Outcome measures were amenorrhea rate, UFS-HRQoL scoring, AUB retreatment/reintervention, bleeding days, and perioperative adverse events, through 12 months. Results: Of 26 enrolled women, 24 were available through study completion. Lesions were 27% myomas and 73% polyps. Procedure room time was 19±13 minutes. Complete lesion eradication occurred in 96% of women. At 12 months, amenorrhea prevalence was 46% (p<0.0001 vs. baseline), and 87% of women reported either no bleeding or normalized bleeding. Bleeding/spotting days decreased from 15.7±7.4 to 3.1±4.2 days/month (p<0.0001), symptom severity decreased from 75±13 to 12±18 points (p<0.0001), and QoL scores increased from 29±18 to 88±23 points (p<0.0001). Three women required additional AUB intervention. Perioperative adverse events were minor nausea (n=1) and abdominopelvic cramping (n=2) without sequelae. Conclusion: Sequential hysteroscopic morcellation and endometrial radiofrequency ablation of intrauterine lesions in women with AUB increases amenorrhea rate, alleviates bleeding symptoms, and improves quality of life, with an acceptable safety profile.

MiniArc single-incision sling in the office setting.

STUDY OBJECTIVE: To report MiniArc single-incision sling efficacy results in the office setting and the feasibility of performing the procedure in the office. DESIGN: Prospective, single-arm, nonrandomized, institutional review board-approved study (Canadian Task Force classification II-2). SETTING: Three in-office clinical sites in the United States. PATIENTS: Thirty-eight patients who underwent treatment of stress urinary incontinence using the MiniArc single-incision sling. INTERVENTION: A MiniArc single-incision sling was placed in 38 patients in an office-based setting under intravenous or oral sedation and/or local anesthesia. MEASUREMENTS AND MAIN RESULTS: Thirty-eight implant recipients were evaluated for effectiveness and safety via qualitative (Urinary Distress Inventory-Short Form [UDI-6] and Incontinence Impact Questionnaire-Short Form [IIQ-7]) and quantitative (1-hour pad-weight test and cough stress test) measurements at 3 clinical sites. Secondary outcome measures included procedure time, estimated blood loss, length of stay, perioperative complications, Wong-Baker Faces Pain Scale, and adverse events. During the study, 38 women (mean [SD; 95% CI] age, 48.1 (8.4; 45.3-50.8 years)) received slings. Mean procedure time was 10.6 minutes, estimated blood loss was 23.2 mL, and length of stay was 1.3 hours. At discharge, the Wong-Baker pain score was 0.2 (0.0-2.0). At 2 years, 31 patients were available for follow-up. Of these, 93.5% had normal findings on the cough stress test, and 90.3% had pad weight <1 g; and 90.6% and 87.5%, respectively, using last failure carried forward analysis in 32 patients. The UDI-6 and IIQ-7 median scores showed a statistically significant decrease from baseline (p < .001). There were no reports of serious adverse events or of bowel, urethral, bladder, or major vessel perforation. CONCLUSION: The in-office experience suggests that implantation of a single-incision sling for treatment of stress urinary incontinence with the patient under intravenous or oral sedation and/or local anesthesia can be performed safely, with effective results. Thus, performing this procedure in an office setting is a viable option.

Botulinum toxin type A for the treatment of provoked vestibulodynia: an open-label, pilot study.

OBJECTIVE: To evaluate the effects of botulinum toxin type Afor the treatment of provoked vestibulodynia. STUDY DESIGN: Open-label, dose-escalation, pilot study. Primary outcome measure was a standard numeric pain rating scale of 0-10. Secondary measures were improvements in quality of life and change in medication use. RESULTS: The 7 patients who received 35 units of botulinum toxin type A had a baseline mean pain score (0-10) of 8.1 (SD = 0.70). Thirty days after treatment, these patients had a mean pain score of 2.9 (SD= 1.17). The duration of effect was 8 weeks, and there were no side effects. The 12 patients who received 50 units of botulinum toxin type A had a baseline mean pain score of 7.4 (SD = 0.10). Thirty days after treatment, these patients had a mean pain score of 1.8 (SD= 0.72). The duration of effect was 14 weeks, and there were no side effects. Significant improvement was also seen in medication use and quality of life for these patients. CONCLUSION: This study provides further clinical evidence of the nociceptive effects of botulinum toxin type A in pelvic inflammatory pain-related disorders. Doubleblind, placebo-controlled trials to evaluate the efficacy of botulinum toxin in treating patients with provoked vestibulodynia are warranted.

Laparoscopic uterine suspension for pain relief: a multicenter study.

OBJECTIVE: To assess the efficacy of laparoscopic positioning by ligament investment, fixation and truncation (UPLIFT) in alleviating pain in women with a symptomatic, retroverted uterus, the duration of pain relief, and operative or postoperative complications associated with the procedure. STUDY DESIGN: Between May 22, 1998, and November 16, 2000, 62 women with a retroverted uterus, chronic pelvic pain, moderate to severe dysmenorrhea and/or dyspareunia underwent UPLIFT on an outpatient basis. The patients for this prospective, cohort study were recruited from 5 private gynecologic practices. The patients were asked to rate their pelvic pain, dysmenorrhea and dyspareunia on a scale of 0-10, with 0 no pain and 10 the worst pain imaginable, preoperatively and again at 4 weeks and 3, 6 and 12 months postoperatively. The average follow-up time was 10.2 months (range, 0.2-14.9). RESULTS: The mean scores for pelvic pain decreased from 7.3 to 3.7 at 12 months (n = 46). Dysmenorrhea decreased from 7.8 to 4.4 (n = 39), and dyspareunia decreased from 8.0 to 3.3 (n=41). All p values were <0.0001. There were 5 minor intraoperative adverse events. The procedure did not result in any postoperative complications. CONCLUSION: UPLIFT resulted in significant, long-term pain reduction in women with a symptomatic, retroverted uterus.

Randomized comparative trial of cervical block protocols for pain management during hysteroscopic removal of polyps and myomas.

PURPOSE: To evaluate the efficacy of two cervical block protocols for pain management during hysteroscopic removal of intrauterine polyps and myomas using the MyoSure(®) device. PATIENTS AND METHODS: This was a randomized, comparative treatment trial conducted by five private Obstetrics and Gynecology practices in the USA. Forty premenopausal women aged 18 years and older were randomized to receive either a combination para/intracervical block protocol of 37 cc local anesthetic administered at six injections sites in association with the application of topic 1% lidocaine gel, or an intracervical block protocol of 22 cc local anesthetic administered at three injections sites without topical anesthetic, for pain management during hysteroscopic removal of intrauterine polyps and/or a single type 0 or type 1 submucosal myoma ≤3 cm. The main outcomes were a composite measure of procedure-related pain and pain during the postoperative recovery period, assessed by the Wong-Baker Faces Rating Scale (0= no pain to 10= maximum pain). The lesion characteristics, procedure time, and adverse events were summarized. RESULTS: A total of 17 polyps and eight myomas were removed in the para/intracervical block group, with diameters of 1.3±0.5 cm and 1.8±0.8 cm, respectively. In the intracervical block group, 25 polyps with a mean diameter of 1.2±0.7 cm and 7 myomas with a mean diameter of 1.9±0.9 cm were removed. The mean tissue resection time was 1.2±2.0 minutes and 1.2±1.4 minutes for the para/intracervical and intracervical block groups, respectively. The mean composite procedure-related pain score was low for both cervical block protocols, 1.3±1.4 in the para/intracervical block group vs 2.1±1.5 in the intracervical block group. During the postoperative recovery period, the mean pain scores were 0.3±0.7 vs 1.2±1.7 for the para/intracervical and intracervical block groups, respectively. There were no serious adverse events. CONCLUSION: The MyoSure procedure for removal of polyps and myomas was well tolerated, with low pain scores reported for both the para/intracervical and intracervical block protocols.

Vessel sealing using a pulsed bipolar system and open forceps.

We evaluated the vessel-sealing ability of one application of a pulsed plasma kinetic (PK) electrosurgical device on skeletonized vessels up to 7 mm in diameter to withstand sustained pressure of 300 mm Hg using bench and animal models. Forty-six porcine specimens and 66 abattoir vessels (112 total) were pressure tested after sealing with a pulsed PK system. Of these, 108 (96%) met the criterion of 300 mm Hg pressure held for 10 seconds without leaking. The PK system open forceps effectively closes vessels and maintains closure at a pressure level sufficient for clinical use. The device is more effective than clips, sutures, and staples.

Acute and long-term outcomes of radio frequency bladder neck suspension.

PURPOSE: A new treatment modality for women with stress urinary incontinence secondary to urethral hypermobility is radio frequency bladder neck suspension. Radio frequency energy is a form of electromagnetic energy that is reliable and highly controllable. This thermal therapy can produce well-defined areas of tissue heating. The technology has been used extensively in dermatological and orthopedic surgery for tissue shrinkage and ablation. Radio frequency thermal therapy is now being applied to the endopelvic fascia at the bladder neck and urethra for treating hypermobility in patients with stress urinary incontinence. The purported mechanism is shrinkage of the collagenated tissue that supports the bladder neck and proximal urethra. We report our acute and long-term experience with laparoscopic radio frequency bladder neck suspension for stress urinary incontinence. MATERIALS AND METHODS: Enrolled in this prospective multicenter trial were 94 women with a mean age of 48.4 +/- 7.6 years who had urethral hypermobility with an average cotton swab angle change of 41 degrees and Valsalva leak point pressures greater than 90 cm. water at 250 ml. bladder capacity. Detrusor instability was excluded by cystometry. In all cases precisely controlled radio frequency energy was applied to the endopelvic fascia to heat and shrink the tissue. The primary end points were physician assessment of continence, patient reported pad use and the number of patient reported episodes of urinary incontinence daily 1, 3, 6 and 12 months after surgery. RESULTS: Average operative time was less than 60 minutes and 98% of the patients were discharged home from the recovery room. Treatment surface area decreased an average of 17% in length and 21% in width. Preoperatively 78% of patients had an average of 1 or more episodes of urinary incontinence daily. At 1, 3, 6 and 12 months there was an average of 1 or fewer episodes of urinary incontinence daily in 84.7%, 85.6%, 85.9% and 77.4% of patients, respectively, and at 12 months 83.5% reported being continent or improved. Preoperatively 41.2% of patients reported using 1 pad or less daily, while at 1, 3, 6 and 12 months 85.6%, 90.4%, 87.2% and 86.9%, respectively, required 1 pad or less daily. Urodynamic evaluation at 12 months showed no leakage during the Valsalva maneuver in 78% of cases. There were no major postoperative complications and the minor complication rate was 5.3%. CONCLUSIONS: Early results of thermal treatment of the endopelvic fascia indicate that radio frequency bladder neck suspension is safe and effective for improving stress urinary incontinence in women. The improvement in symptomatology appears to be durable in most patients at the 1-year followup. Longer followup is needed to assess the durability of results and it is currently in progress.