Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-02-04 @ 1:28 AM
Study NCT ID:
NCT00506766
Status:
COMPLETED
Last Update Posted:
2007-07-25
First Post:
2007-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Promoting Self Care to Prevent Urinary Incontinence (UI): A Four-Year Follow-up
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 360}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-07', 'completionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-07-23', 'studyFirstSubmitDate': '2007-07-23', 'studyFirstSubmitQcDate': '2007-07-23', 'lastUpdatePostDateStruct': {'date': '2007-07-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence to PMFT and BT (self efficacy) were measured through questionnaires and 3-day voiding diaries.', 'timeFrame': 'Every 6 months for 4 years'}], 'secondaryOutcomes': [{'measure': 'Adherence to PMFT and BT (self efficacy) were measured through questionnaires and days of urinary incontinence per 3-day voiding diary', 'timeFrame': 'Every 6 months for 4 years'}, {'measure': 'Digital measurement during clinical examination of pelvic muscle function (pressure and displacement).', 'timeFrame': '1/year for four years'}, {'measure': 'Paper towel bladder test', 'timeFrame': '1/year for four years'}, {'measure': 'Survey questions (open ended and forced choice) about strategies women use to incorporate PFMT and BT into their lives', 'timeFrame': '1 time'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Urinary Incontinence', 'Self efficacy', 'Pelvic floor muscle training', 'Bladder training'], 'conditions': ['Urinary Incontinence', 'Bladder Control']}, 'referencesModule': {'references': [{'pmid': '17228060', 'type': 'RESULT', 'citation': 'Hines SH, Seng JS, Messer KL, Raghunathan TE, Diokno AC, Sampselle CM. Adherence to a behavioral program to prevent incontinence. West J Nurs Res. 2007 Feb;29(1):36-56; discussion 57-64. doi: 10.1177/0193945906293793.'}, {'pmid': '16868693', 'type': 'RESULT', 'citation': 'Messer KL, Herzog AR, Seng JS, Sampselle CM, Diokno AC, Raghunathan TE, Hines SH. Evaluation of a mass mailing recruitment strategy to obtain a community sample of women for a clinical trial of an incontinence prevention intervention. Int Urol Nephrol. 2006;38(2):255-61. doi: 10.1007/s11255-006-0018-1.'}, {'pmid': '16237512', 'type': 'RESULT', 'citation': 'Sampselle CM, Messer KL, Seng JS, Raghunathan TE, Hines SH, Diokno AC. Learning outcomes of a group behavioral modification program to prevent urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2005 Nov-Dec;16(6):441-6. doi: 10.1007/s00192-005-1284-7. Epub 2005 Mar 15.'}, {'pmid': '15586150', 'type': 'RESULT', 'citation': "Sampselle CM, Palmer MH, Boyington AR, O'Dell KK, Wooldridge L. Prevention of urinary incontinence in adults: population-based strategies. Nurs Res. 2004 Nov-Dec;53(6 Suppl):S61-7. doi: 10.1097/00006199-200411006-00010."}, {'pmid': '14625427', 'type': 'RESULT', 'citation': 'Sampselle CM. Teaching women to use a voiding diary. Am J Nurs. 2003 Nov;103(11):62-4. doi: 10.1097/00000446-200311000-00031. No abstract available.'}, {'pmid': '14767293', 'type': 'RESULT', 'citation': 'Diokno AC, Sampselle CM, Herzog AR, Raghunathan TE, Hines S, Messer K, Karl C, Leite MC. Prevention of urinary incontinence by behavioral modification program: a randomized, controlled trial among older women in the community. J Urol. 2004 Mar;171(3):1165-71. doi: 10.1097/01.ju.0000111503.73803.c2.'}, {'pmid': '12612489', 'type': 'RESULT', 'citation': 'Sampselle CM. Behavioral interventions in young and middle-age women: simple interventions to combat a complex problem. Am J Nurs. 2003 Mar;Suppl:9-19. doi: 10.1097/00000446-200303001-00003. No abstract available.'}, {'type': 'RESULT', 'citation': "Longworth, J, Davila, Y, Sampselle, CM. (2003) La perdida de orina: Hispanic women's experience of urinary incontinence. Hispanic Health Care International (The official Journal of the National Association of Hispanic Nurses), Vol. 2(1), 13-21."}, {'pmid': '37811598', 'type': 'DERIVED', 'citation': 'Funada S, Yoshioka T, Luo Y, Sato A, Akamatsu S, Watanabe N. Bladder training for treating overactive bladder in adults. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013571. doi: 10.1002/14651858.CD013571.pub2.'}]}, 'descriptionModule': {'briefSummary': 'This study examined whether self-efficacy promoted adherence to Pelvic Floor Muscle Training (PFMT) and Bladder Training (BT) in women aged 55 and older.', 'detailedDescription': 'The study was designed to determine the capacity of self-efficacy to predict maintenance of the practices of PFMT and BT. Women in the treatment arm of the RCT attended a Bladder Health Class (PFMT \\& BT) to prevent UI. The class content emphasized self-efficacy. At 3-months post intervention the self-efficacy of participants was measured; these results were collected to analyze for predictive capacity of training adherence. For four years participants in both the treatment and control (no class) arms were followed with both questionnaires and 3-day bladder diaries (2/year) and clinic evaluations of (1/year). In addition, qualitative analyses of the narratives of Bladder Health Class participants identified individual attitudes and strategies that either facilitated or deterred adherence.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 55 years or older who report 5 or fewer episodes of UI / year, no prior treatment for UI, no neurological disease, no difficulties performing activities of daily living\n\nExclusion Criteria:\n\n* Less than 55 years old, UI episodes greater that 5 per year, score of less than 24 on Mini Mental Status Examination'}, 'identificationModule': {'nctId': 'NCT00506766', 'briefTitle': 'Promoting Self Care to Prevent Urinary Incontinence (UI): A Four-Year Follow-up', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Promoting Self Care to Prevent Urinary Incontinence (UI): A Four-Year Follow-up', 'orgStudyIdInfo': {'id': '5R01NR007618-02', 'link': 'https://reporter.nih.gov/quickSearch/5R01NR007618-02', 'type': 'NIH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Bladder Health Class consisting of 6 weekly group sessions', 'type': 'BEHAVIORAL', 'description': '1 time'}, {'name': 'Practice PFMT and BT', 'type': 'BEHAVIORAL', 'description': 'As needed for 4 years'}, {'name': 'Clinic examination for pelvic muscle function', 'type': 'BEHAVIORAL', 'description': '1/year for 4 years'}, {'name': 'Record keeping in 3-day voiding diary', 'type': 'BEHAVIORAL', 'description': 'Every 6 months for 4 years'}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Carolyn M Sampselle, PhD,RNC,FAAN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan School of Nursing'}, {'name': 'Sandra H Hines, PhD, RNC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Michigan School of Nursing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}}}}