Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2026-03-07 @ 11:01 PM
Study NCT ID:
NCT02983461
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-16
First Post:
2016-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Sildenafil for Treatment of Urinary Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}], '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'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068677', 'term': 'Sildenafil Citrate'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2016-12-02', 'studyFirstSubmitQcDate': '2016-12-05', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary Incontinence as measured by Pad Test', 'timeFrame': '10 weeks', 'description': 'Pad tests quantitatively measures urine leakage'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['urinary incontinence', 'pelvic floor dysfunction'], 'conditions': ['Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'The investigators goal is to develop medical treatments for stress/mixed urinary incontinence. Sildenafil has been shown to improve blood flow as well as muscle mass and strength and to decrease muscle fatigue. The investigators believe that it will improve muscular atrophy in the pelvic floor, thus improving symptoms of urinary incontinence related to pelvic floor dysfunction.', 'detailedDescription': 'Aim: To determine the effect of sildenafil on urinary incontinence.\n\n1. Episodes of urinary incontinence will be recorded using a 3 day bladder diary.\n2. Quantitative assessment of urinary incontinence will be performed at baseline and after treatment using a Pad Test.\n3. Muscle strength will be assessed through use of a perineometer.\n4. To evaluate macrocirculatory blood flow in pelvic organs, women will be assessed with noninvasive imaging before and after randomization to sildenafil.\n5. Secondary outcomes will include evaluation of muscle and vaginal mucosal thickness.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Postmenopausal females, 50-80 years of age, at the time of consent\n* Have stress or mixed urinary incontinence, with at least 3 episodes/week\n* Willing and able to comply with study procedures\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Significant heart, liver, kidney, pulmonary, blood, autoimmune or peripheral vascular disease (history of Hashimoto's thyroiditis is not exclusionary if stable and thyroid replacement is being administered. Thyroid testing will be performed at screening and as needed during study visits. )\n* Systolic blood pressure \\<100 or \\>150, diastolic blood pressure \\<60 or \\>90 after repeated evaluation with proper cuff. This range is smaller than the acceptable range stated in the prescribing information for sildenafil (\\>90/50 and \\<170/110)\n* Diabetes mellitus or other untreated endocrine disease\n* Active cancer\n* Currently using and planning to continue use of urinary incontinence medications during study period\n* BMI \\> 40\n* HIV, Hepatitis B, or Hepatitis C\n* Use of systemic nitrates, anabolic steroids or corticosteroids in the past 6 months\n* Use of alpha blockers\n* Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation.\n* Known allergic reaction to any agent under investigation or required by the protocol.\n* History of prior non-compliance or the presence or history of psychiatric condition (including drug or alcohol addiction) that would, in the opinion of the investigator, make it difficult for the subject to comply with the study procedures or follow the investigators instructions.\n* Females who are pregnant or lactating."}, 'identificationModule': {'nctId': 'NCT02983461', 'briefTitle': 'Use of Sildenafil for Treatment of Urinary Incontinence', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Medical Branch, Galveston'}, 'officialTitle': 'Use of Sildenafil for Treatment of Urinary Incontinence', 'orgStudyIdInfo': {'id': '15-0121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Double Blind Placebo 3 times a day for 10 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sildenafil', 'description': 'Double Blind Sildenafil, 20mg x 3 times a day, 10 weeks.', 'interventionNames': ['Drug: Sildenafil']}], 'interventions': [{'name': 'Sildenafil', 'type': 'DRUG', 'description': 'Sildenafil, 20mg x 3 times a day for 10 weeks', 'armGroupLabels': ['Sildenafil']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo oral tablet, 3 times a day for 10 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}], 'overallOfficials': [{'name': 'Kathleen L Vincent, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Medical Branch, Galveston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}