NCT00667550

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

July 15, 2010

Status Verified

July 1, 2010

Enrollment Period

2 years

First QC Date

April 24, 2008

Last Update Submit

July 13, 2010

Conditions

Lower Urinary Tract SymptomsColorectal Disorders

Keywords

Lower urinary tract symptomsColorectal disordersUrinary incontinenceFecal incontinenceVoiding dysfunctionUrgency frequencySexual dysfunctionColorectal malignanciesInflammatory bowel disease

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Subjects less than 18 years of age
  • Subjects unable to give informed consent or complete the validated questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Lower Urinary Tract SymptomsUrinary IncontinenceFecal IncontinenceSexual Dysfunction, PhysiologicalInflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Urological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesGenital DiseasesGastroenteritis

Study Officials

  • Karen L Noblett, M.D.

    University of California, Irvine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 24, 2008

First Posted

April 28, 2008

Study Start

March 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

July 15, 2010

Record last verified: 2010-07

Locations

US(1)