Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2026-03-11 @ 4:18 PM
Study NCT ID:
NCT01657916
Status:
COMPLETED
Last Update Posted:
2017-06-09
First Post:
2012-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
5-Year Objective and Subjective Results of a Mid-Urethral Sling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}, {'id': 'D016055', 'term': 'Urinary Retention'}], 'ancestors': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'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': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-08', 'studyFirstSubmitDate': '2012-08-02', 'studyFirstSubmitQcDate': '2012-08-03', 'lastUpdatePostDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cough stress test', 'timeFrame': '5 year follow up appt', 'description': 'Patient will void and their post-void residual amount of urine will be obtained by a catheter. That same catheter will be left in place and used to fill the bladder with 250ml sterile saline. The patient will then be asked to vigorously cough in the upright sitting and standing positions. A positive "cough test" will be defined as any leakage of urine that is visualized during coughing in the sitting or standing position.'}], 'secondaryOutcomes': [{'measure': 'Pelvic exam', 'timeFrame': '5 year follow up appt', 'description': 'Standardized pelvic exam will be performed to assess healing, palpability, mesh related pain and erosion of the sling.'}, {'measure': 'Stress urinary incontinence related symptoms', 'timeFrame': '5 year follow up appointment', 'description': 'Validated stress urinary incontinence related questionnaires were completed prior to surgery by all of these patients, and will be completed 5 years after surgery as well. The specific forms used will be PFDI-20 and incontinence severity index. Question 17 of the pelvic floor distress inventory will be used to assess subjective cure.'}, {'measure': 'Urgency incontinence related symptoms', 'timeFrame': '5 year follow up appointment', 'description': 'Patients will be assessed for de novo, stable and improved urgency incontinence using the IIQ-7 subject of PFDI-20 (questions 15, 16, and 18).'}, {'measure': 'Quality of life and self-reported data', 'timeFrame': '5 year follow up appointment', 'description': "Validated questionnaires (Incontinence outcome questionnaire, surgical satisfaction questionaire) will be used to assess patient's surgery satisfaction, subjective self-assessment before and 5 years after the surgery."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['mid-urethral sling', 'Align urethral support system', 'tension free vaginal tape', 'cough stress test', 'pelvic exam', 'PFDI-20', 'PFIQ', 'SSQ', 'Urinary retention', 'mesh erosion', 'urodynamics'], 'conditions': ['Stress Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'Evaluate 5-year objective and subjective cure rates after implant of the retropubic Align Urethral Support System.', 'detailedDescription': 'Between June 2007 and December 2008, the investigators performed 155 Align mid-urethral slings in patients who were only receiving this operation. Very few studies have outcomes at 5 years of greater. The aim of this prospective cohort study is to evaluate five-year objective and subjective cure rates. Secondary endpoints will assess failure risk factors and describe any complications of the retropublic Align Urethral Support System five years postoperatively.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'women who suffered from stress urinary incontinence (leakage of urine will laughing/coughing/sneezing/exercising)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women\n* complaint of stress urinary incontinence\n* underwent Align urethral support system from June 2007-December 2008\n\nExclusion Criteria:\n\n* concommitant procedures'}, 'identificationModule': {'nctId': 'NCT01657916', 'briefTitle': '5-Year Objective and Subjective Results of a Mid-Urethral Sling', 'organization': {'class': 'OTHER', 'fullName': 'Atlantic Health System'}, 'officialTitle': '5-Year Objective and Subjective Results of a Mid-Urethral Sling', 'orgStudyIdInfo': {'id': 'R12-01-005'}}, 'armsInterventionsModule': {'armGroups': [{'label': '5 year sling implants', 'description': 'Patients who underwent implant of the Align Urethral Support System between June 2007 and December 2008'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07960', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Atlantic Health System', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atlantic Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}