Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2026-01-03 @ 9:28 PM
Study NCT ID:
NCT00667550
Status:
COMPLETED
Last Update Posted:
2010-07-15
First Post:
2008-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lower Urinary Tract and Sexual Function in Women Following Surgery for Colorectal Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D005242', 'term': 'Fecal Incontinence'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-13', 'studyFirstSubmitDate': '2008-04-24', 'studyFirstSubmitQcDate': '2008-04-24', 'lastUpdatePostDateStruct': {'date': '2010-07-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lower urinary tract symptoms', 'Colorectal disorders', 'Urinary incontinence', 'Fecal incontinence', 'Voiding dysfunction', 'Urgency frequency', 'Sexual dysfunction', 'Colorectal malignancies', 'Inflammatory bowel disease'], 'conditions': ['Lower Urinary Tract Symptoms', 'Colorectal Disorders']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.\n\nFew studies have looked at the incidence of lower urinary tract symptoms and sexual dysfunction in patients with colorectal conditions before and after surgery.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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\n* Females have English as a primary language\n\nExclusion Criteria:\n\n* Subjects less than 18 years of age\n* Subjects unable to give informed consent or complete the validated questionnaires"}, 'identificationModule': {'nctId': 'NCT00667550', 'briefTitle': 'Lower Urinary Tract and Sexual Function in Women Following Surgery for Colorectal Disorders', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Lower Urinary Tract and Sexual Function in Women Following Surgery for Colorectal Disorders', 'orgStudyIdInfo': {'id': '2007-5995'}}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Irvine Medical Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}], 'overallOfficials': [{'name': 'Karen L Noblett, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Irvine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Karen Noblett, Associate Professor', 'oldOrganization': 'University of California, Irvine Medical Center'}}}}