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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03140852
Other study ID # 2017-0133
Secondary ID A532840SMPH\OBST
Status Completed
Phase N/A
First received
Last updated
Start date April 25, 2017
Est. completion date November 1, 2017

Study information

Verified date December 2019
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 122
Est. completion date November 1, 2017
Est. primary completion date November 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 50 Years and older
Eligibility Inclusion Criteria: - qualifying symptoms within last 3 months - able to speak English - lives independently Exclusion Criteria: - new treatment for target symptoms within last 3 months

Study Design


Intervention

Behavioral:
Mind Over Matter; Healthy Bowels, Healthy Bladder
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.

Locations

Country Name City State
United States University of Wisconsin-Madison School of Medicine and Public Health Madison Wisconsin

Sponsors (3)

Lead Sponsor Collaborator
University of Wisconsin, Madison National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Wisconsin Partnership Program

Country where clinical trial is conducted

United States, 

References & 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: — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Symptom Improvement Patient Global Impression of Improvement (PGI-I) regarding bladder or bowel incontinence 3 months after treatment group completes intervention
Secondary Pelvic Floor Distress Inventory-20 validated instrument 3 months after treatment group completes intervention
Secondary Geriatric Self-Efficacy for Urinary Incontinence (GSE-UI) validated instrument 3 months after treatment group completes intervention
Secondary Barriers to Care-seeking for Accidental Bowel Leakage (BCABL) validated instrument 3 months after treatment group completes intervention
Secondary Barriers to Incontinence Care-seeking (BICS-Q) validated instrument 3 months after treatment group completes intervention
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Completed NCT03176901 - Comparing Approaches to Treat Older Adult Women's Urge Incontinence: Pilot Feasibility and Randomized Controlled Trial N/A
Active, not recruiting NCT06200922 - Telehealth in the Rehabilitation of Urinary Incontinence in Older Women N/A