Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2026-01-04 @ 8:45 PM
Study NCT ID:
NCT01747993
Status:
TERMINATED
Last Update Posted:
2014-10-02
First Post:
2012-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tamsulosin for Urinary Retention in Hospitalized Older Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016055', 'term': 'Urinary Retention'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077409', 'term': 'Tamsulosin'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'whyStopped': 'low inclusion', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-01', 'studyFirstSubmitDate': '2012-12-10', 'studyFirstSubmitQcDate': '2012-12-11', 'lastUpdatePostDateStruct': {'date': '2014-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'early catheter removal failure', 'timeFrame': 'between days 3 and 6', 'description': 'need to replace a catheter within 72h following day 3 catheter removal'}], 'secondaryOutcomes': [{'measure': 'hospital-acquired urinary tract infection', 'timeFrame': 'between days 1 and 12', 'description': 'any symptomatic urinary tract infection proved by urine culture'}, {'measure': 'orthostatic hypotension', 'timeFrame': 'days 1 to 6', 'description': 'blood pressure drop \\> 20/10 mmHg between lying and standing'}, {'measure': 'length of hospitalization', 'timeFrame': 'from day 1', 'description': 'number of days in the ward where the patient was enrolled'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Urinary retention; urinary catheterization; alpha blocking agents; women; elder'], 'conditions': ['Urinary Retention']}, 'descriptionModule': {'briefSummary': 'Catheter-associated urinary infections are the most common hospital-acquired infections and can be prevented by early catheter removal. This study evaluates tamsulosin to reduce the failure of early catheter removal has been studied in elderly women hospitalized for an acute condition and experiencing acute urinary retention: 448 women 75-year old or more without an anatomical or neurological cause of urinary retention will be randomized to a 6 days course of tamsulosin 0.4 mg or placebo. Catheter removal will be attempted after the third dose of tamsulosin and the need to replace another catheter within 72 hours will define a failed attempt.', 'detailedDescription': "Background: Urinary tract infections are the most frequent hospital-acquired infections. A majority is catheter-associated and the main risk factor is the duration of catheterization. Early removal is therefore a priority. Treatment with alpha-blockers in men with acute urinary retention due to prostatic disease increases the rate of successful early catheter removal. No intervention has been studied in elderly women in whom urinary retention is usually favored by an acute health issue. However, alpha-blockers have proved effective in other circumstances, as the prevention of acute urinary retention after hysterectomy and the treatment of chronic voiding disorders.\n\nObjective: To evaluate the benefit of tamsulosin for 6 days in older women hospitalized for an acute medical condition and experiencing urinary retention.\n\nPrimary endpoint: Rate of failed early catheter removal (day 3), requiring placement of another catheter within the following 72 hours.\n\nSecondary endpoints: rate of hospital-acquired urinary tract infections, rate of hypotension, length of hospitalization.\n\nDesign: Double-blind and multicentric randomized controlled trial (tamsulosin 0.4 mg/day or placebo orally for 6 days).\n\nNumber of patients: We assume a 40% failure rate of early catheter removal in the placebo group. Expecting a 10% dropout rate, 448 patients need to be randomized to show a reduction of this rate by one third in the tamsulosin group with two-sided alpha level at 5% and beta level at 20%.\n\nInclusion criteria: 75-year or older women hospitalized in an internal medicine or geriatric ward and with a bladder catheter for less than 48 hours for acute urinary retention.\n\nNon-inclusion criteria: chronic urinary retention; acute retention with an anatomical (pelvic tumor, pelvic surgery) or neurological cause (peripheral neuropathy, spinal cord compression, multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease); catheter placed for another indication (pressure ulcer protection, urine output monitoring); patients at the end of life; contra-indication to alpha-blockers.\n\nCourse of the study: The patient receives a treatment dose in the evening inclusion (day 0) and the five following evenings. The catheter is removed after the third dose, between midnight and noon. The patient is followed up until day 12.\n\nTotal time: 36 months (35 months of inclusion + 12 days of participation per patient).\n\nNumber of participating centers: 8 Expected number of inclusions per month and center: 2-4"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 75-year or older women hospitalized in an internal medicine or geriatric ward and with a bladder catheter for less than 48 hours for acute urinary retention.\n\nExclusion Criteria:\n\n* chronic urinary retention;\n* acute retention with an anatomical (pelvic tumor, pelvic surgery) or neurological cause (peripheral neuropathy, spinal cord compression, multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease);\n* catheter placed for another indication (pressure ulcer protection, urine output monitoring);\n* patient at the end of life;\n* contra-indication to alpha-blockers."}, 'identificationModule': {'nctId': 'NCT01747993', 'acronym': 'TAMSU', 'briefTitle': 'Tamsulosin for Urinary Retention in Hospitalized Older Women', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Tamsulosin to Facilitate Early Catheter Removal After Urinary Retention in Older Women Hospitalized for an Acute Medical Condition', 'orgStudyIdInfo': {'id': 'P 101005'}, 'secondaryIdInfos': [{'id': 'AOR11001', 'type': 'OTHER', 'domain': 'Assistance Publique'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tamsulosin', 'description': 'Tamsulosin (0.4 mg/j) (1 tablet / day for 6 days)', 'interventionNames': ['Drug: Tamsulosin (0.4 mg/j)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': '1 tablet / day for 6 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tamsulosin (0.4 mg/j)', 'type': 'DRUG', 'description': '(1 tablet / day for 6 days)', 'armGroupLabels': ['tamsulosin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '(1 tablet / day for 6 days)', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75020', 'city': 'Paris', 'country': 'France', 'facility': 'Service de médecine interne, Hôpital Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Eric Bouvard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}