International Urogynecology Journal

Transvaginal mesh usage has been at the forefront of popular media and academic debate for the past 10 years. Several US Food and Drug Administration (FDA) communications, society statements, and research articles have been written in an attempt to define and articulate the classification system, safety data, and efficacy of this approach to transvaginal surgery. In this review, we explore the history of transvaginal mesh surgery for pelvic organ prolapse (POP), review FDA and society statements, and research current practice in the United States. We searched the English language literature using PubMed for articles related to safety and monitoring of transvaginal mesh and reviewed all FDA publication and notices and gynecology and urogynecology society statements on its use in the United States. We then reviewed 22 articles and grouped them into several sections. Mesh used to augment transvaginal repair of POP was introduced in the United States in 2005 without clinical safety and efficacy data. In the subsequent years of use, both major and minor complications were increasingly reported, leading to several FDA notifications and warnings. The type of mesh used, reporting and classifications systems, and provider usage has varied widely over time. We present a historical review of transvaginal mesh use for pelvic organ prolapse in the United States from 2005 to 2016. There continues to be heated debate among practitioners about balancing the efficacy of mesh use to decrease recurrent prolapse and complications. Research into safety and efficacy, along with tighter FDA regulations, is ongoing.

Mixed urinary incontinence (MUI) can be a challenging condition to manage. We describe the protocol design and rationale for the Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence (ESTEEM) trial, designed to compare a combined conservative and surgical treatment approach versus surgery alone for improving patient-centered MUI outcomes at 12 months. ESTEEM is a multisite, prospective, randomized trial of female participants with MUI randomized to a standardized perioperative behavioral/pelvic floor exercise intervention plus midurethral sling versus midurethral sling alone. We describe our methods and four challenges encountered during the design phase: defining the study population, selecting relevant patient-centered outcomes, determining sample size estimates using a patient-reported outcome measure, and designing an analysis plan that accommodates MUI failure rates. A central theme in the design was patient centeredness, which guided many key decisions. Our primary outcome is patient-reported MUI symptoms measured using the Urogenital Distress Inventory (UDI) score at 12 months. Secondary outcomes include quality of life, sexual function, cost-effectiveness, time to failure, and need for additional treatment. The final study design was implemented in November 2013 across eight clinical sites in the Pelvic Floor Disorders Network. As of 27 February 2016, 433 total/472 targeted participants had been randomized. We describe the ESTEEM protocol and our methods for reaching consensus for methodological challenges in designing a trial for MUI by maintaining the patient perspective at the core of key decisions. This trial will provide information that can directly impact patient care and clinical decision making.

Large bladder masses are typically found to be malignant in nature. We present a case of a large bladder neck mass as a result of previous imprecise collagen injection for urethral bulking. The patient was successfully treated as an outpatient with transurethral excision of the collagen mass combined with post-operative anticholinergic therapy.

The objective of this study was to identify risk factors and urodynamic parameters predictive of mid-urethral sling (MUS) revision surgery that can be used for counseling patients and individualizing risk prediction. Retrospective case-control analysis of 40 sling revisions performed during the 12-year study period were compared to 123 control cases that did not require revision to obtain a 1:3 case-to-control ratio. Demographic, perioperative, and urodynamic data were analyzed, with p < 0.05 as significant. Independent predictors of sling revision were assessed by binary logistic regression models, with risk expressed as adjusted odds ratios. After multiple regression analysis, younger age at time of index MUS placement (aOR 0.93, 95% CI 0.88–0.97), increasing number of cesarean deliveries (CD) (aOR 2.00, 95% CI 1.01–3.96), and concomitant apical prolapse repair during index MUS procedure (aOR 4.63, 95% CI 1.34–15.93) were significant predictors of sling revision. Young age at the time of placement, multiple CD, and concomitant apical prolapse repair were independent factors predictive of sling revision. Giving consideration to risk factors could improve patient counseling and surgical candidate selection.

The aim of this study was to evaluate urinary symptoms in the postpartum period after omission of the bladder flap at the time of primary cesarean delivery. This was a single-blind parallel-group randomized comparison (bladder flap, no bladder flap) in women scheduled for a primary cesarean delivery at 37 weeks gestation or later. The primary outcome was urinary symptom scores at 6–8 weeks postpartum. Secondary outcomes included comparisons of preoperative and postoperative pelvic floor symptom scores and the proportions of symptom bother responses between the study groups. A total 43 women were available for analysis. Randomization was as follows: omission of the bladder flap (n = 22) and bladder flap (n = 21). Demographic characteristics and baseline pelvic floor symptom scores were similar between the groups. The primary outcome, urinary symptom scores at 6–8 weeks postpartum, did not differ significantly between the groups, but urinary symptom bother was significantly higher in women who received a bladder flap. Pelvic floor symptom scores improved significantly following delivery. Urinary symptom scores as measured by the UDI-6 did not differ between women randomized to bladder flap or omission of the bladder flap, but the proportion of women with urinary symptom bother was significantly higher among those who received a bladder flap.