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.

Does vaginal size impact sexual activity and function?

INTRODUCTION AND HYPOTHESIS: This study seeks to determine if total vaginal length (TVL) or genital hiatus (GH) impact sexual activity and function. METHODS: Heterosexual women >or= 40 years were recruited from urogynecology and gynecology offices. TVL and GH were assessed using the Pelvic Organ Prolapse Quantification exam. Women completed the Female Sexual Function Index (FSFI) and were dichotomized into either normal function (FSFI total > 26) or sexual dysfunction (FSFI

Evaluation and treatment of anal incontinence, constipation, and defecatory dysfunction.

Posterior compartment disorders include anal incontinence, constipation, and defecatory dysfunction. These disorders cause considerable morbidity, and are typically underreported by patients and undertreated by providers. The purpose of this article is outline the approach to diagnosis and treatment of anal incontinence, constipation, and defecatory dysfunction with a brief description of the nature of the problem and approaches to evaluation and diagnosis, as well as medical and surgical management.

Shortcomings/strengths of specific sexual function questionnaires currently used in urogynecology: a literature review.

Pelvic floor disorders are common and although not life-threatening, have a significant impact on a patient's quality of life. Sexual health is an essential component of a women's overall well-being. In clinical practice and research it is important that the symptoms and impact of these disorders are assessed in an objective fashion. The most valid instruments to measure the presence, severity, and impact of a patient's pelvic floor symptoms on function and quality of life are sexual function questionnaires. Sexual function questionnaires range from ad hoc questionnaires to condition-specific validated measures. This review article will describe the shortcomings and strengths of a variety of validated sexual function questionnaires currently used to measure sexual function in women with pelvic floor disorders.

Validation of Spanish versions of the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ): a multicenter validation randomized study.

INTRODUCTION AND HYPOTHESIS: The purpose of this study is to validate Spanish versions of the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ). METHODS: Spanish versions were developed using back translation and validation was performed by randomizing bilingual women to complete the Spanish or English versions of the questionnaires first. Weighted kappa statistics assessed agreement for individual questions; interclass correlation coefficients (ICC) compared primary and subscale scores. Cronbach's alpha assessed internal consistency of Spanish versions. To detect a 2.7 point difference in scores with 80% power and alpha of 0.05, 44 bilingual subjects were required. RESULTS: Individual questions showed good to excellent agreement (kappa > 0.6) for all but eight questions on the PFIQ. ICCs of primary and subscale scores for both questionnaires showed excellent agreement. (All ICC > 0.79). All Cronbach's alpha values were excellent (>0.84) for the primary scales of both questionnaires. CONCLUSIONS: Valid and reliable Spanish versions of the PFIQ and PFDI have been developed.