Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT03587402
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2018-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Transcutaneous Perineal Stimulation Versus Anal Stimulation
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Single Blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-06', 'studyFirstSubmitDate': '2018-06-27', 'studyFirstSubmitQcDate': '2018-07-13', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects of transcutaneous perineal stimulation compared to anal stimulation', 'timeFrame': 'Baseline, 6 and 10 weeks', 'description': 'A change of the urine grams last in 24 hours'}], 'secondaryOutcomes': [{'measure': 'Asses quality of life', 'timeFrame': 'Baseline and 10 weeks', 'description': 'Asses the perceived quality of life of patients in the study. It will be evaluated with the questionnaire I-QOL. It measures the effect of urinary incontinence on quality of life.\n\nThe I-QOL have 22 items and is divided into 3 subscales: avoidance and limiting behavior, psychosocial impact, social embarrassment. More puntuation means more quality of life.'}, {'measure': 'Assess adverse effects', 'timeFrame': '10 weeks', 'description': 'Identify adverse effects for each of the treatments'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urinary Incontinence', 'Radical Prostatectomy', 'Pelvic Floor']}, 'referencesModule': {'references': [{'pmid': '33509164', 'type': 'DERIVED', 'citation': 'Pane-Alemany R, Ramirez-Garcia I, Carralero-Martinez A, Blanco-Ratto L, Kauffmann S, Sanchez E. Efficacy of transcutaneous perineal electrostimulation versus intracavitary anal electrostimulation in the treatment of urinary incontinence after a radical prostatectomy: randomized controlled trial study protocol. BMC Urol. 2021 Jan 28;21(1):12. doi: 10.1186/s12894-020-00718-y.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates whether surface perineal stimulation is as effective as anal stimulation in reducing urinary incontinence secondary to radical prostatectomy.\n\nHalf of participants will receive a treatment with surface perineal stimulation, while the other half will receive a treatment with anal stimulation.', 'detailedDescription': 'Pelvic floor muscle training is the most common non-invasive intervention for urinary incontinence secondary to radical prostatectomy. Perineal stimulation has a significant positive impact on the early recovery of urinary continence after this intervention.\n\nThe perineal stimulation can be applied with surface electrodes or with an intra-cavitary probe placed in the anus. The two techniques are commonly used. Each techniques stimulates different anatomical points of perineum, and it is a question if both have the same effectiveness or, one of the two techniques has greater effect than the other.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'As it is a prostatic pathology, only men participate in the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having undergone a radical prostatectomy surgical procedure.\n* Presenting involuntary urine losses after radical prostatectomy intervention. (IU grade I, II or III)\n* Do not exceed the year since the surgical intervention.\n* Accept to participate in the study and grant signed informed consent.\n\nExclusion Criteria:\n\n* Follow a pharmacological treatment for the UI.\n* Presenting anatomical malformations of the pelvic floor musculature.\n* Carry pacemaker.\n* Present anal fistulas.\n* suffer from serious psychic disorders.\n* Presenting lower urinary tract infections.'}, 'identificationModule': {'nctId': 'NCT03587402', 'briefTitle': 'Effects of Transcutaneous Perineal Stimulation Versus Anal Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'RAPbarcelona'}, 'officialTitle': 'Effects of Transcutaneous Perineal Stimulation Versus Anal Stimulation on Urinary Incontinence After Radical Prostatectomy', 'orgStudyIdInfo': {'id': 'RAP47747176G'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcutaneous perineal stimulation', 'description': 'Patient is asked to lie down with legs slightly bend and two adhesive electrodes are attached transcutaneous on base of penis and on perineum. Stimulation current is administrated half time with a fixed frequency of 30 Hz and half time with 50 Hz. Pulse increased until the patient perceives the current. Sessions lasted for 30 minutes weekly for 10 weeks.', 'interventionNames': ['Other: Transcutaneous perineal stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Anal stimulation', 'description': 'Patient is asked to lie down with legs slightly bend and an electrical probe is inserted into the anus. Stimulation current is administrated half time with a fixed frequency of 30 Hz and half time with 50 Hz. Pulse increased until the patient perceives the current. Sessions lasted for 30 minutes weekly for 10 weeks.', 'interventionNames': ['Other: Anal stimulation']}], 'interventions': [{'name': 'Transcutaneous perineal stimulation', 'type': 'OTHER', 'description': 'Surface stimulation', 'armGroupLabels': ['Transcutaneous perineal stimulation']}, {'name': 'Anal stimulation', 'type': 'OTHER', 'description': 'Intra-cavitary stimulation', 'armGroupLabels': ['Anal stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08037', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Regina Pané Alemany', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Regina Pané', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RAPbarcelona'}, {'name': 'Inés Ramírez', 'role': 'STUDY_DIRECTOR', 'affiliation': 'RAPbarcelona'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RAPbarcelona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Regina Pané Alemany', 'investigatorAffiliation': 'RAPbarcelona'}}}}