Pilot: Mind Over Matter: Healthy Bowels, Healthy Bladder

NCT ID: NCT02671747

Last Updated: 2019-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Urinary Incontinence Fecal Incontinence Accidental Bowel Leakage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pilot workshop

Participants attend intervention. No control arm

Group Type EXPERIMENTAL

Mind Over Matter; Healthy Bowels, Healthy Bladder

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* qualifying symptoms in 3 months prior to enrollment

Exclusion Criteria

* receiving new treatment for qualifying symptoms in 3 months prior to enrollment
Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Heidi Brown, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2015-0942

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Prevent Inability To Control Urination
NCT00075114 COMPLETED PHASE3
Postpartum Pelvic Floor Workshop
NCT04754984 COMPLETED NA