Evaluate Women After Vaginal Surgery for Urinary Symptoms and Sexual Function
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|ClinicalTrials.gov Identifier: NCT00376441|
Recruitment Status : Completed
First Posted : September 14, 2006
Last Update Posted : August 23, 2011
|Condition or disease||Intervention/treatment|
|Urinary Incontinence Pelvic Organ Prolapse Surgery||Procedure: Vaginal Surgery|
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.
|Study Type :||Observational|
|Actual Enrollment :||41 participants|
|Observational Model:||Case Control|
|Official Title:||Study of Sexual Function and Urinary Symptoms in Women Having Vaginal Surgeries|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||January 2009|
Procedure: Vaginal Surgery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00376441
|United States, Michigan|
|William Beaumont Hospital|
|Royal Oak, Michigan, United States, 48073|
|Principal Investigator:||Kenneth Peters, M.D.||William Beaumont Hospitals|