Risk factors for mesh extrusion after prolapse surgery: a case-control study.

OBJECTIVES: To identify risk factors for mesh extrusion in women undergoing pelvic organ prolapse repair by abdominal sacral colpopexy (ASC) or vaginal mesh procedure (VMP). METHODS: A multicenter case-control study of patients who underwent ASC or VMP from 2006 to 2009 identified using diagnosis and procedure coding. Cases were defined as women who underwent eligible index procedure with synthetic mesh and had mesh visible through the vaginal epithelium at postoperative evaluation; controls were matched in an approximate 1:3 ratio by date and type of procedure. Two conditional logistic regression models were constructed to assess variables associated with mesh extrusion among women who underwent ASC and among women who underwent VMP. RESULTS: Eighty-four cases were identified (43 cases after ASC and 41 cases after VMP), and 252 patients were matched as controls (147 patients who underwent ASC and 105 patients who underwent VMP). Concomitant hysterectomy was positively associated with mesh extrusion) among women who underwent ASC (adjusted odds ratio, 3.18; 95% confidence interval, 1.27-7.93; P = 0.01) and VMP (adjusted odds ratio, 3.72, 95% confidence interval, 1.20-11.54; P = 0.02). Age, race, type of vaginal incision, menopausal status, medical comorbidities, and smoking were not significantly associated with extrusion in either group. CONCLUSIONS: Concomitant hysterectomy is a risk factor for mesh extrusion after ASC and VMPs. This information may be helpful during informed preoperative counseling and planning.

Institutional review board variability in minimal-risk multicenter urogynecology studies.

OBJECTIVES: To investigate variability among local institutional review boards (IRBs) in the review process of standardized multicenter urogynecologic studies with common protocols. METHODS: Descriptive study of the IRB review and approval process for common urogynecologic protocols of 4 minimal-risk multicenter studies conducted within the Fellow's Pelvic Research Network (FPRN), including prospective cohort, retrospective review, and case-control studies. RESULTS: Most of the 22 network sites (73%) were in academic institutions. The level of IRB review varied by site and study design. Institutional review boards had local requirements regarding standard format and language that resulted in 86% of consent documents and 33% of protocols being changed before submission. Institutional review boards queried most (55%) submissions, with significantly more queries for prospective studies compared to retrospective studies (78.6% vs 35.3%; P = 0.03). After submission, IRB requirements necessitated changes for 71% of consents and 28% of protocols. There were no substantive changes made to any consent document or protocol. There was considerable variability in time between IRB submission and approval (10 ± 3 days; range, 7-12 days for exempt; 22 ± 17 days; range, 1-57 days for expedited; and 34 ± 32 days; range, 13-81 days for full board reviews). CONCLUSIONS: We detected considerable variability in IRB review of standardized multicenter protocols across minimal-risk study designs. Reduction in variability may improve expediency of multicenter studies while maintaining the highest level of protections for research participants.

Risk factors leading to midurethral sling revision: a multicenter case-control study.

INTRODUCTION AND HYPOTHESIS: To determine risk factors for sling revision after midurethral sling (MUS) placement. METHODS: This multicenter case-control study included patients who underwent MUS placement and subsequent revision secondary to voiding dysfunction from January 1999-2007 from nine Urogynecology centers across the USA. Direct logistic regression analysis was used to determine which diagnostic variables predicted sling revision. RESULTS: Of the patients, 197 met the study criteria. Patient demographics, urodynamic findings, and operative differences did not increase the risk for sling revision. Risk factors for sling revision did include: pre-existing voiding symptoms (OR 2.76, 95% CI 1.32-5.79; p = 0.004) retropubic sling type (OR = 2.28, 95% CI 1.08-4.78; p = 0.04) and concurrent surgery (OR = 4.88, 95% CI 2.16-11.05; p < 0.001) CONCLUSIONS: This study determined that pre-existing obstructive voiding symptoms, retropubic sling type, and concurrent surgery at the time of sling placement are risk factors for sling revision.

A retrospective multicenter study on outcomes after midurethral polypropylene sling revision for voiding dysfunction.

OBJECTIVES: : The purpose of this study was to determine outcomes of sling revision after midurethral sling (MUS) placement and whether timing of sling revision affected those outcomes. MATERIALS AND METHODS: : This is a multicenter study including patients who underwent MUS placement and subsequent sling revision secondary to voiding dysfunction. Diagnostic outcomes before and after sling revision were compared for all sling revision patients with complete data. Logistic regression analyses were performed to determine if revision timing predicted voiding dysfunction and stress incontinence. RESULTS: : One hundred seventy-five patients who met the study criteria had complete data. Overall, 70% (133) of MUS were retropubic and 30% (56) were obturator slings. Midurethral sling revision was accomplished by cutting (54%), excision (29%), and pulling down on the mesh (18%). Stress urinary incontinence (SUI) resolved in 38%, urinary tract infections (UTIs) in 69%, and overactive bladder (OAB) in 75%. In comparison, 21% experienced de novo SUI; 18%, de novo UTIs; and 12%, de novo OAB symptoms after revision. Voiding dysfunction resolved in 80%, however 10% experienced new voiding dysfunction symptoms. Retropubic slings displayed more voiding dysfunction, higher de novo/worsened OAB, and more UTIs after revision than obturator slings. Sling revision timing did not predict persistent voiding dysfunction but did predict SUI with earlier revision (≤2 weeks) resulting in less postrevision SUI when compared to revisions at 15-90 days or greater than 90 days. The method of sling revision (cut, excised, pulled down) did not predict SUI, OAB, or obstructive voiding symptoms. CONCLUSIONS: : Sling revision resolves voiding dysfunction symptoms, UTIs and post-sling OAB symptoms in the majority of patients. Resolution of voiding dysfunction is independent of method and timing of revision; however earlier revision is associated with decreased postrevision SUI.

Anatomic outcomes of vaginal mesh procedure (Prolift) compared with uterosacral ligament suspension and abdominal sacrocolpopexy for pelvic organ prolapse: a Fellows' Pelvic Research Network study.

OBJECTIVE: The objective of the study was to compare apical support anatomic outcomes following vaginal mesh procedure (VMP) (Prolift) to uterosacral ligament suspension (USLS) and abdominal sacrocolpopexy (ASC). STUDY DESIGN: This multicenter, retrospective chart review compared apical anatomic success (stage 0 or 1 based on point C or D of the Pelvic Organ Prolapse Quantification), level of vaginal apex (point C or D) 3-6 months after prolapse repair at 10 US centers between 2004 and 2007. RESULTS: VMP, USLS, and ASC were performed for 206, 231, and 305 subjects respectively. There was no difference in apical success after VMP (98.8%) compared with USLS (99.1%) or ASC (99.3%) (both P = 1.00) 3-6 months after surgery. The average elevation of the vaginal apex was lower after VMP (-6.9 cm) than USLS (-8.05 cm) and ASC (-8.5 cm) (both P < .001) CONCLUSION: Patients undergoing VMP have similar apical success compared with USLS and ASC despite lower vaginal apex 3-6 month after surgery.

One-year anatomic and quality-of-life outcomes after the Prolift procedure for treatment of posthysterectomy prolapse.

OBJECTIVE: To evaluate anatomic and quality-of-life outcomes at 1-year or greater after treatment of posthysterectomy prolapse with the Prolift procedure. STUDY DESIGN: A retrospective repeated measures study comparing preoperative and 1-year or greater postoperative outcomes, including Pelvic Organ Prolapse Quantification measurements, Urogenital Distress Inventory, and Incontinence Impact Questionnaire scores. RESULTS: Ninety-seven patients were included, with a median follow-up of 19.0 months. Forty-six anterior, 28 posterior, and 23 total Prolift procedures were performed. At 1 year, Pelvic Organ Prolapse Quantification values were significantly improved, as were scores for Incontinence Impact Questionnaire, the Urogenital Distress Inventory, and its subscales, with the greatest improvement seen in the obstructive/discomfort subscale. Anatomical success (/= stage 2 in the untreated vaginal compartment. CONCLUSION: Significant anatomic and quality-of-life improvements among patients undergoing the Prolift procedure for posthysterectomy prolapse were demonstrated.

New minimally invasive slings: TVT Secur.

Single-incision slings are now approved by the US Food and Drug Administration. TVT Secur (Ethicon, Somerville, NJ), the first mini sling available for use, offers a minimally invasive approach to the surgical treatment of stress incontinence, with its greatest benefit being reduced patient discomfort in the immediate postoperative period. Although little data are available regarding the safety and efficacy of this new generation of slings, TVT Secur appears to be relatively safe. Long-term efficacy has not yet been determined, but short-term efficacy rates seem to compare with traditional midurethral mesh slings. Long-term follow-up is warranted and comparative studies are needed to determine its true efficacy.