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

This study has been completed.
Sponsor:
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00667550
First received: April 24, 2008
Last updated: July 13, 2010
Last verified: July 2010
History of Changes

April 24, 2008
July 13, 2010
March 2008
March 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00667550 on ClinicalTrials.gov Archive Site
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Lower Urinary Tract and Sexual Function in Women Following Surgery for Colorectal Disorders
Lower Urinary Tract and Sexual Function in Women Following Surgery for Colorectal Disorders

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Female patients with a diagnosis of a colorectal disorder requiring surgery. Patients must be able to complete the questionnaires in English as the questionnaires are only available and valid in English.
  • Lower Urinary Tract Symptoms
  • Colorectal Disorders
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
March 2010
March 2010   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00667550
2007-5995
Yes
Karen Noblett, Associate Professor, University of California, Irvine Medical Center
University of California, Irvine
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Principal Investigator: Karen L Noblett, M.D. University of California, Irvine
University of California, Irvine
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP