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

NCT00506766 | Completed Phase 3

• 1 other identifier: 5R01NR007618-02
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Urinary Incontinence; Bladder Control

Keywords

Urinary Incontinence; Self efficacy; Pelvic floor muscle training; Bladder training

Outcome Measures

Primary Outcomes (1)

• Adherence to PMFT and BT (self efficacy) were measured through questionnaires and 3-day voiding diaries.

  Every 6 months for 4 years

Secondary Outcomes (4)

• Adherence to PMFT and BT (self efficacy) were measured through questionnaires and days of urinary incontinence per 3-day voiding diary

  Every 6 months for 4 years

• Digital measurement during clinical examination of pelvic muscle function (pressure and displacement).

  1/year for four years

• Paper towel bladder test

  1/year for four years

• Survey questions (open ended and forced choice) about strategies women use to incorporate PFMT and BT into their lives

  1 time

Interventions

Bladder Health Class consisting of 6 weekly group sessions BEHAVIORAL

1 time

Practice PFMT and BT BEHAVIORAL

As needed for 4 years

Clinic examination for pelvic muscle function BEHAVIORAL

1/year for 4 years

Record keeping in 3-day voiding diary BEHAVIORAL

Every 6 months for 4 years

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (9)

• 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: 17228060 RESULT

• 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: 16868693 RESULT

• 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: 16237512 RESULT

• 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: 15586150 RESULT

• 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: 14625427 RESULT

• 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: 14767293 RESULT

• 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.

  PMID: 12612489 RESULT

• 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.

  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.

  PMID: 37811598 DERIVED

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carolyn M Sampselle, PhD,RNC,FAAN

  University of Michigan School of Nursing

  PRINCIPAL INVESTIGATOR

• Sandra H Hines, PhD, RNC

  University of Michigan School of Nursing

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 23, 2007
• First Posted: July 25, 2007
• Study Start: September 1, 2000
• Study Completion: August 1, 2006
• Last Updated: July 25, 2007

Record last verified: 2007-07

Locations

US (1)