Promoting Self Care to Prevent Urinary Incontinence (UI): A Four-Year Follow-up - Full Text View

Purpose

This study examined whether self-efficacy promoted adherence to Pelvic Floor Muscle Training (PFMT) and Bladder Training (BT) in women aged 55 and older.

Condition	Intervention	Phase
Urinary Incontinence Bladder Control	Behavioral: Bladder Health Class consisting of 6 weekly group sessions Behavioral: Practice PFMT and BT Behavioral: Clinic examination for pelvic muscle function Behavioral: Record keeping in 3-day voiding diary	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind Primary Purpose: Prevention
Official Title:	Promoting Self Care to Prevent Urinary Incontinence (UI): A Four-Year Follow-up

Resource links provided by NLM:

MedlinePlus related topics: Urinary Incontinence Urine and Urination

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:

Adherence to PMFT and BT (self efficacy) were measured through questionnaires and 3-day voiding diaries. [ Time Frame: Every 6 months for 4 years ]

Secondary Outcome Measures:

Adherence to PMFT and BT (self efficacy) were measured through questionnaires and days of urinary incontinence per 3-day voiding diary [ Time Frame: Every 6 months for 4 years ]
Digital measurement during clinical examination of pelvic muscle function (pressure and displacement). [ Time Frame: 1/year for four years ]
Paper towel bladder test [ Time Frame: 1/year for four years ]
Survey questions (open ended and forced choice) about strategies women use to incorporate PFMT and BT into their lives [ Time Frame: 1 time ]

Enrollment:	360
Study Start Date:	September 2000
Study Completion Date:	August 2006

Intervention Details:

1 time

As needed for 4 years

1/year for 4 years

Every 6 months for 4 years

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	55 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Less than 55 years old, UI episodes greater that 5 per year, score of less than 24 on Mini Mental Status Examination

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00506766

Locations

United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

University of Michigan

Investigators

Principal Investigator:	Carolyn M Sampselle, PhD,RNC,FAAN	University of Michigan School of Nursing
Study Director:	Sandra H Hines, PhD, RNC	University of Michigan School of Nursing

More Information

Publications:

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.

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.

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. Epub 2005 Mar 15.

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. Review.

Sampselle CM. Teaching women to use a voiding diary. Am J Nurs. 2003 Nov;103(11):62-4. No abstract available.

Diokno AC, Sampselle CM, Herzog AR, Raghunathan TE, Hines S, Messer KL, 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.

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. Review. No abstract available.

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.

ClinicalTrials.gov Identifier:	NCT00506766 History of Changes
Other Study ID Numbers:	5 R01 NR07618-02
Study First Received:	July 23, 2007
Last Updated:	July 23, 2007
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Michigan:

Urinary Incontinence
Self efficacy
Pelvic floor muscle training
Bladder training

Additional relevant MeSH terms:

Urinary Incontinence
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013