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OpenTrials
Completed

NCT Number: NCT02671747

Pilot: Mind Over Matter: Healthy Bowels, Healthy Bladder

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.

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Key information

Conditions

Urinary Incontinence Accidental Bowel Leakage Digestive System Diseases Fecal Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Intestinal Diseases Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

The pilot study will use mixed methods to compare pre- and post-workshop data about urinary and bowel incontinence symptoms and care-seeking from workshop participants as well as information about workshop acceptability from workshop participants and community partners. The study is expected to last 6 months from initial IRB approval through data analysis and workshop revision. This research will provide preliminary data for a larger test of this workshop in four diverse Wisconsin Communities, followed by a randomized, controlled trial and subsequent dissemination research study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • qualifying symptoms in 3 months prior to enrollment

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

  1. urinary incontinence symptoms for participant with bladder symptoms

    Time frame: 3 months after workshop completion

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

  2. bowel incontinence symptoms for participant with bowel symptoms

    Time frame: 3 months after workshop completion

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

Secondary outcomes

  1. geriatric self-efficacy score for urinary incontinence

    Time frame: 3 months after workshop completion

    Difference between baseline and 3 month follow up on Geriatric Self-Efficacy for Urinary Incontinence scale

  2. barriers to care-seeking for urinary incontinence

    Time frame: 3 months after workshop completion

    Score on the Barriers to Incontinence Care-Seeking Questionnaire (BICS-Q) at three month follow up as compared to baseline

  3. barriers to care-seeking for accidental bowel leakage

    Time frame: 3 months after workshop completion

    Barriers to Care-Seeking for Accidental Bowel Leakage responses - difference from baseline to 3 month follow up

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

Pilot Testing for Mind Over Matter: Healthy Bowels, Healthy Bladder

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 2, 2016
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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