NCT00075114

Brief Summary

The purpose of this study is to determine the capacity of self-efficacy to predict maintaining a behavior change at four years post urinary control intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
417

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2000

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2002

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 5, 2004

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

January 15, 2015

Status Verified

January 1, 2015

Enrollment Period

1.4 years

First QC Date

January 2, 2004

Last Update Submit

January 14, 2015

Conditions

Urinary Incontinence

Keywords

Self CareBehavior Modification

Outcome Measures

Primary Outcomes (1)

  • Mean number of incontinence episodes

    Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline

Secondary Outcomes (3)

  • Pelvic floor muscle strength

    Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline

  • Length of voiding interval

    Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline

  • Self-efficacy

    Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline

Study Arms (2)

1 Bladder Health Class

OTHER

A two-hour bladder health class presented by two experts in urinary incontinence and followed by an individual follow-up teaching session with an incontinence nurse specialist.

Behavioral: Bladder Health Class

2 Control Group

NO INTERVENTION

Participants randomized to this arm did not receive any interventions.

Interventions

Bladder Health ClassBEHAVIORAL

A two-hour bladder health class presented by two experts in urinary incontinence and followed by an individual follow-up teaching session with an incontinence nurse specialist.

1 Bladder Health Class

Eligibility Criteria

Age55 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Female 55 through 80 years old
  • Post-menopausal-no menstrual cycle for the past 12 months except for women who are on hormone replacement therapy.
  • Continent of urine (using the MESA definition of continence) defined as:
  • No previous incontinence episode except during pregnancy and/or postpartum period.
  • Urine loss less than 6 days during the last 365 days
  • No previous or present incontinence treatment with pharmacological agents, behavioral programs or surgical therapy.
  • No history of bladder cancer, stroke, multiple sclerosis, parkinsonism, epilepsy, spinal cord tumor or trauma.
  • No reported difficulty with activities of daily living, i.e. walking about the house, dressing, getting in/out of bed, getting to/using the toilet, bathing/showering, or eating.
  • Additional criteria are applied at a physical examination:
  • Mini Mental Status of at least 24
  • Negative for objective urine loss during coughing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • 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: 37811598DERIVED

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Carolyn M Sampselle, PhD, APH

    University of Michigan, School of Nursing, MICHIN Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Carolyne K. Davis Professor of Nursing

Study Record Dates

First Submitted

January 2, 2004

First Posted

January 5, 2004

Study Start

September 1, 2000

Primary Completion

February 1, 2002

Study Completion

April 1, 2006

Last Updated

January 15, 2015

Record last verified: 2015-01

Locations

US(1)