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
  Purpose

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
Lower Urinary Tract Symptoms
Colorectal Disorders

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lower Urinary Tract and Sexual Function in Women Following Surgery for Colorectal Disorders

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Enrollment: 34
Study Start Date: March 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
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: NCT00667550

Locations
United States, California
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
  More Information

No publications provided

Responsible Party: Karen Noblett, Associate Professor, University of California, Irvine Medical Center
ClinicalTrials.gov Identifier: NCT00667550     History of Changes
Other Study ID Numbers: 2007-5995
Study First Received: April 24, 2008
Last Updated: July 13, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Lower urinary tract symptoms
Colorectal disorders
Urinary incontinence
Fecal incontinence
Voiding dysfunction
Urgency frequency
Sexual dysfunction
Colorectal malignancies
Inflammatory bowel disease

Additional relevant MeSH terms:
Lower Urinary Tract Symptoms
Disease
Urological Manifestations
Signs and Symptoms
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014