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Evaluate Women After Vaginal Surgery for Urinary Symptoms and Sexual Function

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00376441
Enrollment
41
Registered
2006-09-14
Start date
2006-08-31
Completion date
2009-01-31
Last updated
2011-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence, Pelvic Organ Prolapse, Surgery

Keywords

vaginal, incontinence, sexual function

Brief summary

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

Detailed description

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.

Interventions

patients undergoing vaginal surgery

Sponsors

Corewell Health East
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026