Skip to main content
OpenTrials
Completed

NCT Number: NCT00376441

Evaluate Women After Vaginal Surgery for Urinary Symptoms and Sexual Function

Assess the outcomes of vaginal surgeries and its impact on sexual function and urinary symptoms.

Completed

Looking for future studies?

Notify Me

Key information

About this study

Currently, up to 43% of women in the United States have female sexual dysfunction (FSD). In a recent study of 109 sexually active women in a urogynecology practice, FSD was noted using the validated Female Sexual Function Index (FSFI) in 64% of the women. Difficulties with sexual function are also associated with pelvic organ prolapse and urinary incontinence. One in nine women will have surgery for incontinence or prolapse in her lifetime. The impact of vaginal surgeries on sexual function and urinary symptoms has been scarcely reported in the literature. The methodology of most of those studies is flawed by the use of questionnaires that were not validated, small sample sizes and no comparison control group. In addition, several studies only focused on one surgical intervention, specific types of incontinence or prolapse, or both. It is difficult to make sense out of the discordant research findings when applying it to our patient population.

This is a prospective study of women with incontinence or pelvic organ prolapse. Subjects will be selected from three urology practices. All patients will be asked to complete a short patient history form. If the woman meets the study criteria, the study will be explained and if she agrees to participate in this study, informed consent will be obtained. She will then complete the FSFI, SF-12 and PFDI-20 questionnaires.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women at least 18 years of age
  • Having urinary incontinence or pelvic organ prolapse
  • Capable of giving informed consent
  • Capable and willing to follow all study related procedures

Exclusion criteria

  • Reported history of urethral obstruction (not secondary to prolapse), stricture, bladder calculi or bladder tumor in the last 2 years.
  • Pregnant as confirmed by urine pregnancy test or plans to become pregnant during the study period.
  • Breast feeding
  • Currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function
  • Cannot independently comprehend and complete the questionnaires.
  • The subject is deemed unsuitable for enrollment in this study by the investigators based on their history or physical examination.

Treatment and study plan

Vaginal Surgery

Procedure

patients undergoing vaginal surgery

Sponsors and collaborators

Lead sponsor

Corewell Health East

Other

Registry information

Official study title

Study of Sexual Function and Urinary Symptoms in Women Having Vaginal Surgeries

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Sep 14, 2006
Registry last updated
Aug 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.