Evaluate Women After Vaginal Surgery for Urinary Symptoms and Sexual Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00376441
First received: September 13, 2006
Last updated: August 19, 2011
Last verified: August 2011
  Purpose

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


Condition Intervention
Urinary Incontinence
Pelvic Organ Prolapse
Surgery
Procedure: Vaginal Surgery

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Study of Sexual Function and Urinary Symptoms in Women Having Vaginal Surgeries

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Enrollment: 41
Study Start Date: August 2006
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Vaginal Surgery
    patients undergoing vaginal surgery
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women at least 18 years of age having urinary incontinence or pelvic organ prolapse.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376441

Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
Principal Investigator: Kenneth Peters, M.D. William Beaumont Hospitals
  More Information

Publications:
Responsible Party: William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00376441     History of Changes
Other Study ID Numbers: 2006-119
Study First Received: September 13, 2006
Last Updated: August 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:
vaginal
incontinence
sexual function

Additional relevant MeSH terms:
Pelvic Organ Prolapse
Urinary Incontinence
Lower Urinary Tract Symptoms
Pathological Conditions, Anatomical
Prolapse
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on October 23, 2014