A multicenter prospective trial evaluating fetal bovine dermal graft (Xenform® Matrix) for pelvic reconstructive surgery.

BACKGROUND: A prospective multicenter clinical study was performed to evaluate the safety and efficacy of a bovine dermal graft (Xenform® Matrix, Boston Scientific, Natick, MA, USA) during vaginal reconstructive surgery. METHODS: Forty-five women with ICS stage 2 or higher pelvic organ prolapse (POP) were enrolled at 4 centers. POP-Q, pelvic floor function (PFDI-20), sexual function (PISQ-12), and patient satisfaction tools were used to assess subjects at baseline, and at 2 and 6 weeks, and 3, 6 and 12 months post surgery. The significance of symptom score changes at 6 months and 1 year were determined by the t-test for paired data. Forty-three of the 45 patients completed the 12 month study. RESULTS: The majority of the subjects had cystocele (98%) and/or rectocele (84%) defects at study entry. At 12 months, 74% of the defects had improved to a stage 0 or 1. Mean PFDI-20 scores improved by 72% (p < 0.001) at 12 months, and PISQ-12 scores were maintained during the follow-up period indicating no decline in sexual function. Three subjects experienced one serious adverse event each; one of the adverse events (constipation) was deemed by the study physician to be unrelated to Xenform®. One subject had severe pyelonephritis resulting in dialysis. This subject had a previous history of pyelonephritis, sepsis and acute renal failure. The third subject had a reported recurrent cystocele of moderate severity, possibly related to the device. No graft related erosions or pain lasting more than 30 days were reported. No subjects withdrew due to an adverse event. CONCLUSION: This study is the first to investigate the use of Xenform® Matrix in vaginal reconstructive surgery among patients with POP. Significant improvement was maintained at 12 months utilizing both objective and subjective assessment tools, confirming the safety and efficacy of this material in vaginal surgery. TRIAL REGISTRATION: ClinicalTrials.gov NCT01244165.

An inexpensive polypropylene patch sling for treatment of intrinsic sphincteric deficiency.

STUDY OBJECTIVE: To evaluate an inexpensive polypropylene sling in patients with intrinsic sphincteric deficiency (ISD). DESIGN: Case series (Canadian Task Force classification II-2). SETTING: Cleveland Clinic Florida teaching hospital. PATIENTS: Analysis of 161 patients with ISD who underwent a surgeon-assembled polypropylene (Prolene) patch sling procedure. INTERVENTION: Polypropylene patch sling surgery was performed in all study patients with urinary stress incontinence due to ISD. MEASUREMENTS AND MAIN RESULTS: All patients underwent urogynecologic evaluation including multichannel urodynamics. Outcome measures included a standardized stress test, patient-reported cure rate, surgical complications, and postoperative voiding dysfunction. Medical records for the 161 patients who underwent the procedure were available for review. Mean patient age was 62.4 years. Twenty-five patients (16%) had concomitant detrusor overactivity. Mean follow-up was 3.6 years. The stress test yielded negative findings in 93.4% of patients. Complete continence was reported by 80.3% of patients, and marked improvement by 7%. The estimated cost of the sling was $17 to $272, depending on the materials used. Two patients experienced urinary retention requiring urethrolysis. Three required sling revision because of healing problems. CONCLUSION: Use of a polypropylene patch sling is an effective treatment for ISD and is less expensive than currently available sling kits.

Anterior repair with or without collagen matrix reinforcement: a randomized controlled trial.

OBJECTIVE: To compare outcomes of anterior colporrhaphy alone to that reinforced with bovine pericardium graft. METHODS: Women with anterior vaginal wall prolapse were enrolled in a randomized fashion in this grafted compared with nongrafted repair study. Outcome measures included pelvic organ prolapse quantification data, quality-of-life assessment, healing abnormalities, and complications. RESULTS: Ninety-four patients were enrolled. Seventy-two (77%) provided 1-year data, and 59 (63%) supplied 2-year data. Demographics and stage of prolapse were similar between groups at baseline. Postoperative complications consisted basically of low urinary tract infection and were low in both groups (10 in bovine pericardium graft and 16 in anterior colporrhaphy alone). One year after surgery, successful anterior vaginal wall support was obtained in 85.7% of the bovine pericardium graft group and 78.4% of anterior colporrhaphy-alone group (P=.544). For the cohort that comprised 2-year analyses, the success rate was 76.5% for the bovine pericardium graft group and 63% for anterior colporrhaphy-alone group (P=.509). Postoperative Urogenital Distress Inventory-6 and Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire-12 scores were uniformly improved over baseline in both groups. CONCLUSION: The use of bovine pericardium graft for anterior vaginal prolapse does not have higher complication rates or healing difficulties. At 1- and 2-year follow-up, anterior colporrhaphy with bovine pericardium reinforcement did not show a statistically significant improvement over colporrhaphy alone. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00860912 LEVEL OF EVIDENCE: I.

Safety and effectiveness of Colpexin Sphere in the treatment of pelvic organ prolapse.

Our objective was to determine the safety and effectiveness of Colpexin Sphere in women with advanced genital prolapse. A total of 39 subjects were enrolled in our prospective multicenter clinical trial, and 27 completed the full 16-week assessment. At baseline, subjects were fitted with a sphere, instructed on insertion and removal, and educated on a regimen of pelvic floor muscle exercises performed with the device in place. Efficacy was evaluated by a baseline vs 16-week comparison of pelvic organ prolapse staging and pelvic floor muscle strength assessment. Safety evaluation included, but was not limited to, an assessment of vaginal mucosal integrity. Subjects also completed a patient satisfaction questionnaire at the end of the study. Improvement in the prolapse of at least one vaginal segment was seen in 81.5% of the subjects, while 63% exhibited improved muscle function on digital examination at 16 weeks. Twenty-five (92.6%) would recommend the device to treat prolapse, and most found it easy to insert (96.3%) and remove (100%). In short-term usage, problems with urination (29.6%) and defecation (72%) were reported, primarily due to device displacement. Two subjects developed superficial vaginal mucosal ulceration, which resolved spontaneously. No significant adverse events were reported.

Safety and efficacy of a testosterone patch for the treatment of hypoactive sexual desire disorder in surgically menopausal women: a randomized, placebo-controlled trial.

BACKGROUND: Oophorectomy reduces serum testosterone levels. We studied the efficacy and safety of transdermal testosterone in treating hypoactive sexual desire disorder in surgically menopausal women. METHODS: A 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial was conducted in women (aged 24-70 years) who developed distressful low sexual desire after bilateral salpingo-oophorectomy and hysterectomy and who were receiving oral estrogen therapy. Women were randomized to receive placebo (n = 119) or testosterone patches in dosages of 150 microg/d (n = 107), 300 microg/d (n = 110), or 450 microg/d (n = 111) twice weekly for 24 weeks. Sexual desire and frequency of satisfying sexual activity were primary efficacy outcome measures. RESULTS: Of the 447 women randomized, 318 (71%) completed the trial. Compared with placebo, women receiving the 300-microg/d testosterone patch had significantly greater increases from baseline in sexual desire (67% vs 48%; P = .05) and in frequency of satisfying sexual activity (79% vs 43%; P = .049). The 150-microg/d group showed no evidence of a treatment effect. The 450-microg/d group also was not statistically different from the 300-microg/d or placebo groups. Marginally significant linear dose-response trends were observed for total satisfying sexual activity and sexual desire at 24 weeks (P = .06 and .06, respectively). Adverse events occurred with similar frequency in both groups; no serious safety concerns were observed. CONCLUSIONS: The 300-microg/d testosterone patch increased sexual desire and frequency of satisfying sexual activity and was well tolerated in women who developed hypoactive sexual desire disorder after surgical menopause.