Pilot: Mind Over Matter: Healthy Bowels, Healthy Bladder

NCT02671747 | Completed

• 1 other identifier: 2015-0942
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is to pilot-test an innovative, combined urinary/bowel continence workshop in two Wisconsin communities. Between 8-15 women with incontinence will be enrolled in each of the two pilot communities and will complete three 90-minute workshop sessions over a 6 week period.

Conditions

Urinary Incontinence; Fecal Incontinence; Accidental Bowel Leakage

Outcome Measures

Primary Outcomes (2)

• urinary incontinence symptoms for participant with bladder symptoms

  1. Change in Urinary Distress Inventory-6 Subscale of Pelvic Floor Distress Inventory-20 from baseline 2. Patient Global Impression of Improvement in urinary symptoms at 3 month follow up

  3 months after workshop completion

• bowel incontinence symptoms for participant with bowel symptoms

  1. Change in Colorectal Anal Distress Inventory-8 Subscale of Pelvic Floor Distress Inventory-20 from baseline 2. Patient Global Impression of Improvement in bowel symptoms at 3 month follow up

  3 months after workshop completion

Secondary Outcomes (3)

• geriatric self-efficacy score for urinary incontinence

  3 months after workshop completion

• barriers to care-seeking for urinary incontinence

  3 months after workshop completion

• barriers to care-seeking for accidental bowel leakage

  3 months after workshop completion

Study Arms (1)

Pilot workshop

EXPERIMENTAL

Participants attend intervention. No control arm

Behavioral: Mind Over Matter; Healthy Bowels, Healthy Bladder

Interventions

Mind Over Matter; Healthy Bowels, Healthy Bladder BEHAVIORAL

3 workshop sessions over a one-month period using self-efficacy and health behavior change to improve incontinence symptoms and promote care-seeking if symptoms do not improve sufficiently

Pilot workshop

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• qualifying symptoms in 3 months prior to enrollment

You may not qualify if:

• receiving new treatment for qualifying symptoms in 3 months prior to enrollment

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

MeSH Terms

Conditions

Urinary Incontinence; Fecal 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; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Heidi Brown, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: February 2, 2016
• Study Start: August 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share