Lower Urinary Tract and Sexual Function in Women Following Surgery for Colorectal Disorders

Sponsor
University of California, Irvine (Other)
Overall Status
Completed
CT.gov ID
NCT00667550
Collaborator
(none)
34
1
24
1.4

Study Details

Study Description

Brief Summary

This is a prevalence study evaluating lower urinary tract, prolapse, bowel, and sexual symptoms in women with a colorectal disorder who are planning to undergo surgery.

The purpose of this study is to identify the number of women who complain of lower urinary tract and bowel problems, including frequency, urgency, urinary incontinence, fecal incontinence, pain with intercourse, and other sexual problems prior to undergoing surgical management for a colorectal disorder.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Lower urinary tract symptoms, including urinary incontinence, voiding dysfunction, urgency, frequency, fecal incontinence, as well as sexual dysfunction, are directly affected by surgery for colorectal disorders. Increased risk of injury to the urinary tract is a recognized complication of pelvic surgery. These risks are related to the radical nature of pelvic surgery used to treat certain colorectal disorders, including colorectal malignancies and inflammatory bowel disease.

    Few studies have looked at the incidence of lower urinary tract symptoms and sexual dysfunction in patients with colorectal conditions before and after surgery.

    The primary goal of this study is to determine the prevalence of lower urinary tract symptoms in women undergoing surgery for colorectal ocnditions. We also want to describe the prevalence of these symptoms in different colorectal disorders, and how pelvic surgery impacts these symptoms.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    34 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Lower Urinary Tract and Sexual Function in Women Following Surgery for Colorectal Disorders
    Study Start Date :
    Mar 1, 2008
    Actual Primary Completion Date :
    Mar 1, 2010
    Actual Study Completion Date :
    Mar 1, 2010

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      Female
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • Female subjects with a diagnosis of a colorectal disorder, including rectal prolapse, inflammatory bowel disease such as Crohn's disease, Ulcerative Colitis, and colorectal malignancies planning to undergo surgery

      • Females have English as a primary language

      Exclusion Criteria:
      • Subjects less than 18 years of age

      • Subjects unable to give informed consent or complete the validated questionnaires

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 University of California, Irvine Medical Center Orange California United States 92868

      Sponsors and Collaborators

      • University of California, Irvine

      Investigators

      • Principal Investigator: Karen L Noblett, M.D., University of California, Irvine

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00667550
      Other Study ID Numbers:
      • 2007-5995
      First Posted:
      Apr 28, 2008
      Last Update Posted:
      Jul 15, 2010
      Last Verified:
      Jul 1, 2010

      Study Results

      No Results Posted as of Jul 15, 2010