Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pilot: Mind Over Matter: Healthy Bowels, Healthy Bladder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02671747
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Fecal Incontinence Accidental Bowel Leakage Behavioral: Mind Over Matter; Healthy Bowels, Healthy Bladder Not Applicable

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pilot Testing for Mind Over Matter: Healthy Bowels, Healthy Bladder
Study Start Date : August 2015
Actual Primary Completion Date : October 1, 2016
Actual Study Completion Date : October 1, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pilot workshop
Participants attend intervention. No control arm
Behavioral: Mind Over Matter; Healthy Bowels, Healthy Bladder
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 Outcome Measures :
  1. urinary incontinence symptoms for participant with bladder symptoms [ Time Frame: 3 months after workshop completion ]
    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

  2. bowel incontinence symptoms for participant with bowel symptoms [ Time Frame: 3 months after workshop completion ]
    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


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • qualifying symptoms in 3 months prior to enrollment

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671747


Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Layout table for investigator information
Principal Investigator: Heidi Brown, MD University of Wisconsin, Madison
Layout table for additonal information
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02671747    
Other Study ID Numbers: 2015-0942
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Fecal Incontinence
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases