MedDataX Logo

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

NCT ID: NCT00506766

Last Updated: 2007-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Study Completion Date

2006-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Urinary Incontinence Bladder Control

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bladder Health Class consisting of 6 weekly group sessions

1 time

Intervention Type BEHAVIORAL

Practice PFMT and BT

As needed for 4 years

Intervention Type BEHAVIORAL

Clinic examination for pelvic muscle function

1/year for 4 years

Intervention Type BEHAVIORAL

Record keeping in 3-day voiding diary

Every 6 months for 4 years

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Michigan

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Carolyn M Sampselle, PhD,RNC,FAAN

Role: PRINCIPAL_INVESTIGATOR

University of Michigan School of Nursing

Sandra H Hines, PhD, RNC

Role: STUDY_DIRECTOR

University of Michigan School of Nursing

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 17228060 (View on PubMed)

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.

Reference Type RESULT
PMID: 16868693 (View on PubMed)

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.

Reference Type RESULT
PMID: 16237512 (View on PubMed)

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.

Reference Type RESULT
PMID: 15586150 (View on PubMed)

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.

Reference Type RESULT
PMID: 14625427 (View on PubMed)

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.

Reference Type RESULT
PMID: 14767293 (View on PubMed)

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.

Reference Type RESULT
PMID: 12612489 (View on PubMed)

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.

Reference Type RESULT

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.

Reference Type DERIVED
PMID: 37811598 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5R01NR007618-02

Identifier Type: NIH

Identifier Source: org_study_id

View Link