Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-01 @ 11:17 PM
Study NCT ID:
NCT05432869
Status:
UNKNOWN
Last Update Posted:
2022-06-27
First Post:
2022-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of External Electrical Stimulating Applied on the Thigh in Men With Urinary Incontinence After Prostatectomy
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-07-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-22', 'studyFirstSubmitDate': '2022-06-22', 'studyFirstSubmitQcDate': '2022-06-22', 'lastUpdatePostDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary incontinence severity', 'timeFrame': 'change from baseline at 4 weeks', 'description': 'Urinary incontinence severity will be assessed with a 1-hour pad test. This amount; less than 2 grams is considered normal, 2-10 grams is mild, 10-50 grams is moderate, and over 50 grams is severe stress urinary incontinence.'}], 'secondaryOutcomes': [{'measure': 'Presence of urinary incontinence symptoms', 'timeFrame': 'change from baseline at 4 weeks', 'description': 'Urinary incontinence symptoms will be assessed with International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF). It consists of 6 questions in total and the total score is 3., 4., 5. It is obtained by adding the scores they get from the questions. A low score in the scale indicates that urinary incontinence symptoms are less.'}, {'measure': 'Life quality', 'timeFrame': 'change from baseline at 4 weeks', 'description': 'Life quality will be assessed with King Health Questionnaire. The questionnaire, consisting of thirty-two items, consists of 2 parts. In the first part, there are 2 questions questioning the general health perception and incontinence effect, and 19 questions dividing the quality of life into 7 areas (role limitations, physical limitations, social limitations, personal relationships, emotional problems, sleep/energy disorders, symptom severity measurement). In the second part, there are 11-item complaint severity scales that evaluate the presence and severity of urinary symptoms. While the best score that can be obtained on the complaint severity scale is "0", the worst score is "30", the best score that can be obtained for all King Health Questionnaire subsections is "0" and the worst score is "100".'}, {'measure': 'Sexual function', 'timeFrame': 'change from baseline at 4 weeks', 'description': 'Sexual function will be assessed with International Index of Erectile Function-5. It includes 5 main topics; erectile function, orgasm function, sexual desire, sexual intercourse satisfaction and general satisfaction are questioned with a total of 5 questions. Each question gets a score between 0-5. Total score; severe (5-7), moderate (8-11), mild-moderate (12-16), mild (17-21), no erectile dysfunction (22-25)'}, {'measure': 'Perception of Subjective Improvement', 'timeFrame': 'after treatment (4th week)', 'description': "Patients' subjective perception of improvement will be questioned with a 4-point Likert scale (worse (1), same (2), better (3) and completely cured (4))"}, {'measure': 'Patients Satisfaction', 'timeFrame': 'after treatment (4th week)', 'description': 'Patient satisfaction will be questioned with a 5-point Likert scale (not at all satisfied (1), dissatisfied (2), undecided (3), satisfied (4), very satisfied (5))'}, {'measure': 'Compliance with Lifestyle Advices', 'timeFrame': 'after treatment (4th week)', 'description': 'Compliance of patients to the lifestyle advices will be evaluated using a 100-mm visual analog scale.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effects of external electrical stimulation applied on the thigh on urinary symptoms, quality of life, sexual function, perception of subjective improvement and satisfaction in men with urinary incontinence after prostatectomy', 'detailedDescription': 'The most common complication after prostatectomy surgeries is urinary incontinence. There are conservative and surgical treatment options in post-prostatectomy urinary incontinence. One of the conservative treatment options is electrical stimulation application.\n\nElectrical stimulation with the intraanal probe in men is painful and uncomfortable.\n\nAnd also there are few studies, demonstrating the effects of electrical stimulation on urinary incontinence after prostatectomy in the literature.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'genderBased': True, 'genderDescription': 'Male with urinary incontinence after prostatectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being a male individual with stress or stress-dominant mixed urinary incontinence symptoms after undergoing prostatectomy surgery\n* Being over 40 years old\n* Not having residual cancerous tissue\n* Volunteering to participate in the study\n\nExclusion Criteria:\n\n* Having serious cardiovascular disease (unstable angina and arrhythmia patients, heart failure patients, etc.)\n* Having sensory loss\n* Having an ongoing urinary infection\n* Having only urgency urinary incontinence\n* Using a pacemaker\n* Receiving active cancer treatment (radiotherapy, chemotherapy)\n* Those who have a problem that interferes with cooperation and understanding'}, 'identificationModule': {'nctId': 'NCT05432869', 'briefTitle': 'Effects of External Electrical Stimulating Applied on the Thigh in Men With Urinary Incontinence After Prostatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Ankara Yildirim Beyazıt University'}, 'officialTitle': 'Effects of External Electrical Stimulating Applied on the Thigh in Men With Urinary Incontinence After Prostatectomy', 'orgStudyIdInfo': {'id': '2022/06/22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electrical stimulation (ES) group', 'description': 'ES group will be given additional external electrical stimulation to the lifestyle advices.', 'interventionNames': ['Other: ES and lifestyle advices']}, {'type': 'EXPERIMENTAL', 'label': 'Control group', 'description': 'Control group will be given only lifestyle advices .', 'interventionNames': ['Other: Lifestyle advices']}], 'interventions': [{'name': 'ES and lifestyle advices', 'type': 'OTHER', 'description': 'The lifestyle advices include fluid consumption, diet, weight control, constipation, smoking, etc.\n\nExternal electrical stimulation will be applied for 30 minutes 3 days a week during 4 weeks. Electrodes were placed on the thighs.', 'armGroupLabels': ['Electrical stimulation (ES) group']}, {'name': 'Lifestyle advices', 'type': 'OTHER', 'description': 'The lifestyle advices include fluid consumption, diet, weight control, constipation, smoking, etc.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Seyda Toprak Celenay', 'role': 'CONTACT', 'email': 'sydtoprak@hotmail.com', 'phone': '+90312 906 1000'}], 'overallOfficials': [{'name': 'Seyda Toprak Celenay', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara Yildirim Beyazıt University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Yildirim Beyazıt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'seyda toprak celenay', 'investigatorAffiliation': 'Ankara Yildirim Beyazıt University'}}}}