Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-01-01 @ 9:32 PM
Study NCT ID:
NCT06948604
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-01
First Post:
2025-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Kegel Exercise on Patient Outcomes Post TURP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 92}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2025-04-14', 'studyFirstSubmitQcDate': '2025-04-21', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'International Prostate Symptom Score', 'timeFrame': 'within 3 month', 'description': 'This tool was developed by Barry et al., (1992) for assessing LUTs after TURP. Post-TURP, patients may continue to experience urinary symptoms such as frequency, urgency, nocturia, and incomplete emptying. International Prostate Symptom Score consists of seven symptom-related questions and one quality-of-life question to assess the severity of LUTs. The symptom questions evaluate incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia, each scored from 0 (never),1(less than 1time in 5), 2 (less than half the time), 3 (about half the time), 4 (more than half the time) to 5 (almost always), with a total score ranging from 0 to 35 (mild: 0-7, moderate: 8-19, severe: 20-35).'}], 'secondaryOutcomes': [{'measure': 'World Health Organization Performance Status Scale', 'timeFrame': 'within 6 month', 'description': 'It developed by Oken et al., (1982) to assess how disease affects daily living abilities of patient and describes the status of symptoms and functions. It consists of: Grade 0: Normal activity, Grade 1: Restricted in physical strenuous activities but ambulatory and able to carry out work of light or sedentary nature, Grade 2: Less than 50% of daytime in bed, Grade 3: More than 50% of daytime in bed, Grade 4: Completely disabled and Grade 5: Dead.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kegel exercise,TURP, Patient outcomes and BPH'], 'conditions': ['BPH (Benign Prostatic Hyperplasia)']}, 'descriptionModule': {'briefSummary': 'how kegel exercise will improve patient outcomes by reducing post TURP LUTs , improve patient performance status and improve patient self esteem', 'detailedDescription': 'patients will divided in to two group study and control, study group will perform kegel exercise postoperative and follow patient progress at 1, 3,6 month while control group receive routine care'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'genderBased': True, 'genderDescription': 'male patient only', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient diagnosed with BPH and undergoing TURP\n* Patient age range from 45-65years old\n* Patient understand verbal and written instructions\n\nExclusion Criteria:\n\nPatient confirmed diagnosis with prostate cancer (biopsy-PSA) Conversion to open prostatectomy Patient has cognitive impairment Patient has chronic cough /chronic bronchitis or asthma'}, 'identificationModule': {'nctId': 'NCT06948604', 'briefTitle': 'Impact of Kegel Exercise on Patient Outcomes Post TURP', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Impact of Kegel Exercises on the Postoperative Outcomes of Patients Undergoing Transurethral Resection of the Prostate', 'orgStudyIdInfo': {'id': 'kegel exercise and TURP outcom'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'kegel exercise', 'description': 'kegel exercise improve muscles strength', 'interventionNames': ['Behavioral: Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'study group and control group', 'description': 'kegel exercise', 'interventionNames': ['Behavioral: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': 'this exercise used to improve urine complication post TURP', 'armGroupLabels': ['kegel exercise', 'study group and control group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer', 'investigatorFullName': 'Hazem Tarraf Abo Dief', 'investigatorAffiliation': 'Assiut University'}}}}