Evaluate Women After Vaginal Surgery for Urinary Symptoms and Sexual Function

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00376441
• Other study ID #: 2006-119
• Status: Completed
• Phase: N/A
• First received: September 13, 2006
• Last updated: August 19, 2011
• Start date: August 2006
• Est. completion date: January 2009

Study information

• Verified date: August 2011
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: January 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Surgery
• Urinary Incontinence

Intervention

Procedure:
• Vaginal Surgery
patients undergoing vaginal surgery

Locations

Country	Name	City	State
United States	William Beaumont Hospital	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

References & Publications (5)

Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the United States: prevalence and predictors. JAMA. 1999 Feb 10;281(6):537-44. Erratum in: JAMA 1999 Apr 7;281(13):1174. — View Citation

LeCroy C. Urinary incontinence occurring during intercourse: effect on sexual function in women. Urol Nurs. 2006 Feb;26(1):53-6. Review. — View Citation

Norton P, Brubaker L. Urinary incontinence in women. Lancet. 2006 Jan 7;367(9504):57-67. Review. — View Citation

Pauls RN, Segal JL, Silva WA, Kleeman SD, Karram MM. Sexual function in patients presenting to a urogynecology practice. Int Urogynecol J Pelvic Floor Dysfunct. 2006 Nov;17(6):576-80. Epub 2006 Jun 8. — View Citation

Weber AM, Walters MD, Schover LR, Mitchinson A. Sexual function in women with uterovaginal prolapse and urinary incontinence. Obstet Gynecol. 1995 Apr;85(4):483-7. — View Citation