NCT03140852

Brief Summary

The goal of this study is to obtain data about the effectiveness, reach, adoption, and implementation potential of an innovative, combined urinary/bowel continence workshop through a randomized controlled trial in six Wisconsin communities. This three-session workshop is based on proven principles of behavior change addressing urinary and bowel continence self-management and health education and has been developed specifically for administration to women age 50 and older in senior centers. We hypothesize that workshop participants will experience improvements in urinary and bowel incontinence symptoms, will have increased levels of care-seeking and self-efficacy for these conditions, and will maintain the self-management strategies taught in the workshop 3 months following completion of the workshop. We further hypothesize that this workshop will reach its intended target population (independent senior women with incontinence) and will improve their mental health by destigmatizing the condition of incontinence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

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

April 25, 2017

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 2, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

August 22, 2025

Status Verified

December 1, 2019

Enrollment Period

6 months

First QC Date

May 2, 2017

Last Update Submit

August 20, 2025

Conditions

Fecal Incontinence in Old AgeUrinary Incontinence in Old Age

Outcome Measures

Primary Outcomes (1)

  • Symptom Improvement

    Patient Global Impression of Improvement (PGI-I) regarding bladder or bowel incontinence

    3 months after treatment group completes intervention

Secondary Outcomes (4)

  • Pelvic Floor Distress Inventory-20

    3 months after treatment group completes intervention

  • Geriatric Self-Efficacy for Urinary Incontinence (GSE-UI)

    3 months after treatment group completes intervention

  • Barriers to Care-seeking for Accidental Bowel Leakage (BCABL)

    3 months after treatment group completes intervention

  • Barriers to Incontinence Care-seeking (BICS-Q)

    3 months after treatment group completes intervention

Study Arms (2)

Treatment

ACTIVE COMPARATOR

Completes the Mind Over Matter; Healthy Bowels, Healthy Bladder workshop in the spring 2017.

Behavioral: Mind Over Matter; Healthy Bowels, Healthy Bladder

Control

OTHER

Completes the Mind Over Matter; Healthy Bowels, Healthy Bladder workshop in the fall 2017.

Behavioral: Mind Over Matter; Healthy Bowels, Healthy Bladder

Interventions

Mind Over Matter; Healthy Bowels, Healthy BladderBEHAVIORAL

This three-session workshop is based on proven principles of behavior change addressing urinary and bowel continence self-management and health education and has been developed specifically for administration to women age 50 and older in senior centers.

ControlTreatment

Eligibility Criteria

Age50 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsself-representation of gender identity
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • qualifying symptoms within last 3 months
  • able to speak English
  • lives independently

You may not qualify if:

  • new treatment for target symptoms within last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin-Madison School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

  • Brown HW, Braun EJ, Wise ME, Myers S, Li Z, Sampene E, Jansen SM, Moberg DP, Mahoney JE, Rogers RG. Small-Group, Community-Member Intervention for Urinary and Bowel Incontinence: A Randomized Controlled Trial. Obstet Gynecol. 2019 Sep;134(3):600-610. doi: 10.1097/AOG.0000000000003422.

    PMID: 31403596RESULT

Study Officials

  • Heidi Brown, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2017

First Posted

May 4, 2017

Study Start

April 25, 2017

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

August 22, 2025

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)