Thirty-six-month Prospective Study of Transvaginal Bovine Graft vs Native Tissue Repair for the Treatment of Pelvic Organ Prolapse.

OBJECTIVE(S): To compare the safety and effectiveness of dermal bovine transvaginal graft, Xenform, to native tissue in the surgical treatment of anterior and/or apical pelvic organ prolapse. This study was designed in conjunction with Food and Drug Administration requirements. METHODS: This was a prospective, non-randomized, parallel cohort, multi-center trial. The primary objective was to demonstrate noninferiority between transvaginal graft and native tissue repair at 36 months compared to baseline. Treatment success was based on a composite of objective and subjective measures. The co-primary outcome was the rate of serious device- or procedure-related adverse events. A total of 228 patients at 25 sites were included in the study arm and 485 patients underwent native tissue repair. Propensity score stratification was applied to achieve balance between treatment groups. Study outcomes were compared in per protocol and intent-to-treat analysis. RESULTS: The primary outcome, treatment success at 36 months, was 83.6% (191/228) for transvaginal graft and 80.5% (390/485) native tissue repair (0.2%, 90% confidence interval [-5.6% to 5.9%]), demonstrating noninferiority at a preset margin of -12%. The overall rate of severe adverse events was 5.3% (12/228) in transvaginal graft vs 2.7% (13/485) in native tissue repair groups. The study group demonstrated noninferiority in serious adverse events at the preset margin of 11.6% (2.0%, 90% confidence interval [-0.8% to 4.7%]). There were no reports of graft erosion, and graft exposure rates were low (0.9% [2/228]). CONCLUSIONS: Transvaginal repair of anterior and/or apical prolapse with a biological graft is noninferior to traditional native tissue repair in effectiveness and safety at 36 months.

An observational cohort study of pelvic floor photobiomodulation for treatment of chronic pelvic pain.

Aim: This research is the first to evaluate the effectiveness of trans-vaginal photobiomodulation therapy (TV-PBMT) for chronic pelvic pain. Materials & methods: Observational analysis of 128 women, undergoing TV-PBMT for chronic pelvic pain. Minimal clinically important difference, defined as ≥2-point drop on a 0-10 numeric pain rating scale (NPRS), and effect size Cohen d coefficient, was calculated over nine treatments for overall pain, and pain with activities. Results: Compared with baseline, 64.5% of women showed improvement in overall pain, pain with bowel movement, intercourse, exercise, urination, sitting and vulvar pain (minimal clinically important difference = -2.4, -2.0, -2.4, -2.1, -2.1, -2.0, -3.1; d = 0.9, 0.7, 0.9, 0.7, 0.7, 0.7, 0.9) by treatment 9. Conclusion: In this cohort, TV-PBMT resulted in improvement of pelvic pain without serious adverse events.

Lay abstract Low-level laser is a therapy that can help pain, but this type of treatment has not been available to women with chronic pelvic pain because traditional laser devices cannot access the pelvic structures. In this research we studied a novel low-laser device that can be used in the vagina, to treat pain arising from pelvic organs and muscles. Our preliminary research shows that this approach significantly reduced pelvic pain, and pain with activities such as exercise, urination, bowel movements and intercourse, in two-thirds of women who completed the therapy.

Early identification of interstitial cystitis may avoid unnecessary hysterectomy.

BACKGROUND: Interstitial cystitis is a clinical syndrome characterized by symptoms of pelvic pain, urinary urgency and frequency, and nocturia. It can be difficult to accurately identify interstitial cystitis because the symptoms overlap many other common gynecologic and urologic conditions. Patients with undiagnosed interstitial cystitis may undergo unnecessary procedures, including hysterectomy. METHODS: A PubMed literature search for articles dating back to 1990 was conducted on the topics of interstitial cystitis and hysterectomy. Further references were identified by cross-referencing the bibliographies in articles of interest. RESULTS: The literature review found that hysterectomy is performed more often in patients with undiagnosed interstitial cystitis than in patients with a confirmed diagnosis. Interstitial cystitis often coexists with conditions like endometriosis, for which hysterectomy is indicated. Many patients subsequently diagnosed with interstitial cystitis continue to experience persistent pelvic pain despite having had a hysterectomy for chronic pelvic pain. Careful history and physical examination can identify the majority of interstitial cystitis cases. CONCLUSION: Interstitial cystitis should be considered prior to hysterectomy in women who present with pelvic pain or who experience pelvic pain after a hysterectomy. If interstitial cystitis is diagnosed, appropriate therapy may eliminate the need for hysterectomy.

Randomized trial of percutaneous tibial nerve stimulation versus extended-release tolterodine: results from the overactive bladder innovative therapy trial.

PURPOSE: The Overactive Bladder Innovative Therapy trial was a randomized, multicenter, controlled study that compared the effectiveness of percutaneous tibial nerve stimulation to extended-release tolterodine. The reduction in overactive bladder symptoms along with global response assessments was evaluated. MATERIALS AND METHODS: A total of 100 adults with urinary frequency were randomized 1:1 to 12 weeks of treatment with weekly percutaneous tibial nerve stimulation or to 4 mg daily extended-release tolterodine. Voiding diaries and an overactive bladder questionnaire were completed at baseline and at the end of therapy to compare 24-hour voiding frequency, urinary urge incontinence episodes, voids causing waking, volume voided, urgency episodes and quality of life indices. Global response assessments were completed by subjects and investigators after 12 weeks of therapy. RESULTS: The global response assessment demonstrated that subject assessment of overactive bladder symptoms compared to baseline was statistically significant in the percutaneous tibial nerve stimulation arm with 79.5% reporting cure or improvement compared to 54.8% of subjects on tolterodine (p = 0.01). Assessments by investigators were similar but did not reach statistical significance (p = 0.05). After 12 weeks of therapy objective measures improved similarly in both groups for reductions in urinary frequency, urge urinary incontinence episodes, urge severity and nighttime voids, as well as for improvement in voided volume. There were no serious adverse events or device malfunctions. CONCLUSIONS: This multicenter, randomized trial demonstrates that percutaneous tibial nerve stimulation is safe with statistically significant improvements in patient assessment of overactive bladder symptoms, and with objective effectiveness comparable to that of pharmacotherapy. Percutaneous tibial nerve stimulation may be considered a clinically significant alternative therapy for overactive bladder.

Positive symptom improvement with laparoscopic uterosacral ligament repair for uterine or vaginal vault prolapse: interim results from an active multicenter trial.

STUDY OBJECTIVE: To evaluate the use of laparoscopic uterosacral ligament repair for long-term patient symptom improvement in patients with uterine prolapse or posthysterectomy vaginal vault prolapse and to evaluate how laparoscopic instrumentation kits facilitate procedure performance for the surgeon. DESIGN: Nonrandomized, prospective, multicenter case series (Canadian Task Force classification II-2). SETTING: Five clinical sites consisting of 4 community hospitals and 1 university medical center. PATIENTS: Seventy-two patients with stage II or worse uterine prolapse (58%, n = 42) or posthysterectomy vaginal vault prolapse (42%, n = 30). One patient with stage I vaginal vault prolapse was included in the group due to her significant symptoms. INTERVENTIONS: Laparoscopic uterosacral ligament repair was performed on all patients; round ligament truncation was also performed selectively on patients with uterine prolapse. Fifty-seven percent (41 patients) had concomitant pelvic procedures. MEASUREMENTS AND MAIN RESULTS: At 12-month follow-up, Pelvic Organ Prolapse Quantification (POP-Q) scores and patient self-reported symptom scores were significantly improved over baseline after laparoscopic repair of pelvic organ prolapse. Positive mean change in POP-Q score was 14.4 (p = .0003) for uterine prolapse repair and 9.28 (p = .017) for vaginal vault prolapse repair. Positive mean change in total symptom score was 20.36 (p <.0001) for uterine prolapse repair and 11.43 (p = .005) for vaginal vault prolapse repair. Surgeons reported a mean procedure time of 31.6 minutes for uterine prolapse repair and 21.7 minutes for vaginal vault prolapse repair. A mean rating of 7.5 was documented for ease of use for the uterine prolapse kit and 4.1 for the vaginal vault prolapse kit on a scale of 1 to 10. CONCLUSION: Laparoscopic uterosacral ligament repair improves symptoms and POP-Q scores over the long term in patients with uterine or vaginal vault prolapse. Laparoscopic instrumentation kits facilitate procedure performance for the surgeon with expedited surgery times.

Postoperative ureteral obstruction after confirmed ureteral patency: a case report.

Ureteral injury after pelvic floor surgery and anti-incontinence surgery is a well-known risk. It is common practice to evaluate ureteral patency immediately after surgery prior to leaving the operating theater to assure that the ureters are open and functional. In this report we discuss the case of a patient who was admitted 9 days after surgery with acute onset of ureteral obstruction after having patent ureters documented at the time of surgery. A literature search failed to show any documented cases.