Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-03-10 @ 7:47 PM
Study NCT ID:
NCT04628351
Status:
COMPLETED
Last Update Posted:
2020-11-17
First Post:
2020-11-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bladder Training in Radical Prostatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}], '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': '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': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-11-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-13', 'studyFirstSubmitDate': '2020-11-07', 'studyFirstSubmitQcDate': '2020-11-07', 'lastUpdatePostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary incontinence-related quality of life assessed by the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)', 'timeFrame': '3 months after from baseline (0 month)', 'description': 'The primary endpoint of this study was the difference between groups in terms of International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) scores 3 months after. This scale consists of 6 questions.The range of scores obtained from the scale varies between 0-21 points. High scores on the scale indicate that the quality of urinary incontinence is severely affected.'}], 'secondaryOutcomes': [{'measure': 'Lower urinary tract symptoms assessed by the International Consultation on Incontinence Questionnaire-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS)', 'timeFrame': '3 months after from baseline (0 month)', 'description': 'The secondary endpoint is the difference between the groups in terms of International Consultation on Incontinence Questionnaire-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) scores after 3 months. This scale consists of 13 questions. Each question has a 4-point severity scale (0-4) and a 10-point visual analog scale (0-10) measuring quality of life. As the scores obtained from the scale increase, complaints about urinary system symptoms increase and the quality is negatively affected.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urinary Incontinence', 'Quality of Life', 'Lower Urinary Tract Symptoms']}, 'referencesModule': {'references': [{'pmid': '22332815', 'type': 'BACKGROUND', 'citation': "Tienforti D, Sacco E, Marangi F, D'Addessi A, Racioppi M, Gulino G, Pinto F, Totaro A, D'Agostino D, Bassi P. Efficacy of an assisted low-intensity programme of perioperative pelvic floor muscle training in improving the recovery of continence after radical prostatectomy: a randomized controlled trial. BJU Int. 2012 Oct;110(7):1004-10. doi: 10.1111/j.1464-410X.2012.10948.x. Epub 2012 Feb 14."}, {'pmid': '24859671', 'type': 'BACKGROUND', 'citation': 'Jarvis TR, Sandhu JS. Management of urinary incontinence after radical prostatectomy. Curr Urol Rep. 2014 Jul;15(7):421. doi: 10.1007/s11934-014-0421-6.'}, {'pmid': '31808408', 'type': 'BACKGROUND', 'citation': 'de Lira GHS, Fornari A, Cardoso LF, Aranchipe M, Kretiska C, Rhoden EL. Effects of perioperative pelvic floor muscle training on early recovery of urinary continence and erectile function in men undergoing radical prostatectomy: a randomized clinical trial. Int Braz J Urol. 2019 Nov-Dec;45(6):1196-1203. doi: 10.1590/S1677-5538.IBJU.2019.0238.'}, {'pmid': '31061057', 'type': 'BACKGROUND', 'citation': 'Hodges P, Stafford R, Coughlin GD, Kasza J, Ashton-Miller J, Cameron AP, Connelly L, Hall LM. Efficacy of a personalised pelvic floor muscle training programme on urinary incontinence after radical prostatectomy (MaTchUP): protocol for a randomised controlled trial. BMJ Open. 2019 May 5;9(5):e028288. doi: 10.1136/bmjopen-2018-028288.'}, {'pmid': '30916232', 'type': 'BACKGROUND', 'citation': 'Bernardes MFVG, Chagas SC, Izidoro LCR, Veloso DFM, Chianca TCM, Mata LRFPD. Impact of urinary incontinence on the quality of life of individuals undergoing radical prostatectomy. Rev Lat Am Enfermagem. 2019 Mar 10;27:e3131. doi: 10.1590/1518-8345.2757.3131.'}, {'pmid': '26610857', 'type': 'BACKGROUND', 'citation': 'Chang JI, Lam V, Patel MI. Preoperative Pelvic Floor Muscle Exercise and Postprostatectomy Incontinence: A Systematic Review and Meta-analysis. Eur Urol. 2016 Mar;69(3):460-7. doi: 10.1016/j.eururo.2015.11.004. Epub 2015 Nov 21.'}]}, 'descriptionModule': {'briefSummary': 'Radical prostatectomy is the gold standard in the treatment of patients with localized prostate cancer. Urinary incontinence, which is common after surgery, can affect the quality of life of men negatively. There are various attempts to prevent and treat urinary symptoms after radical prostatectomy.The aim of this study is to evaluate the effect of the structured bladder training program on lower urinary tract symptoms and quality of life in patients undergoing radical prostatectomy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being over the age of 40 years\n* Being male\n* Being with localized prostate cancer\n* Undergoing open radical prostatectomy\n* No preoperative urinary incontinence\n* Being body mass index\\> 30 kg/m2\n* Agreeing to participate in the research\n* Being literate\n\nExclusion Criteria:\n\n* Having a congenital disorder of the urinary system\n* Having neurological disorders\n* Having a history of transurethral resection of the prostate\n* Having communication and mental impairment\n* Inability to do pelvic floor muscle exercises'}, 'identificationModule': {'nctId': 'NCT04628351', 'briefTitle': 'Bladder Training in Radical Prostatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi'}, 'officialTitle': 'The Effect of Structured Bladder Training Program on Lower Urinary System Symptoms and Quality of Life After Radical Prostatectomy', 'orgStudyIdInfo': {'id': '19/37'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bladder Training', 'description': 'Patients in the structured bladder training group were trained on "lifestyle changes (nutrition, fluid management, exercise), pelvic floor muscle exercises and bladder control techniques".', 'interventionNames': ['Behavioral: Bladder Training']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Routine patient training was given to the patients in the control group by a nurse working in the clinic.'}], 'interventions': [{'name': 'Bladder Training', 'type': 'BEHAVIORAL', 'description': 'Patients in the structured bladder training group were trained on "lifestyle changes (nutrition, fluid management, exercise), pelvic floor muscle exercises and bladder control techniques".', 'armGroupLabels': ['Bladder Training']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Elif Gezginci', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Elif Gezginci, RN, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saglik Bilimleri Üniversitesi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'RN, PHD, Asst Prof', 'investigatorFullName': 'Elif Gezginci', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi'}}}}