Clinical trial NCT00376441: Evaluate Women After Vaginal Surgery for Urinary Symptoms and Sexual Function
Official title: Study of Sexual Function and Urinary Symptoms in Women Having Vaginal Surgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence
Pelvic Organ Prolapse
Surgery
Keywords: vaginal
incontinence
sexual function
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2006-09-14
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women at least 18 years of age having urinary incontinence or pelvic organ prolapse.

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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Kenneth Peters, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Norton P, Brubaker L. Urinary incontinence in women. Lancet. 2006 Jan 7;367(9504):57-67. doi: 10.1016/S0140-6736(06)67925-7.
citation: Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the United States: prevalence and predictors. JAMA. 1999 Feb 10;281(6):537-44. doi: 10.1001/jama.281.6.537.
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. doi: 10.1007/s00192-006-0070-5. Epub 2006 Jun 8.
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. doi: 10.1016/0029-7844(94)00434-F.
citation: LeCroy C. Urinary incontinence occurring during intercourse: effect on sexual function in women. Urol Nurs. 2006 Feb;26(1):53-6. No abstract available.