Clinical trial NCT00667550: Lower Urinary Tract and Sexual Function in Women Following Surgery for Colorectal Disorders
Official title: Lower Urinary Tract and Sexual Function in Women Following Surgery for Colorectal Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Urinary Tract Symptoms
Colorectal Disorders
Keywords: Lower urinary tract symptoms
Colorectal disorders
Urinary incontinence
Fecal incontinence
Voiding dysfunction
Urgency frequency
Sexual dysfunction
Colorectal malignancies
Inflammatory bowel disease
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2008-04-28
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Karen L Noblett, M.D.
role: PRINCIPAL_INVESTIGATOR
References: