Physical Exercise and Bladder Training Program for Urinary Incontinence

• ClinicalTrials.gov Identifier: NCT03869918
• Recruitment Status: Completed
• First Posted: March 11, 2019
• Last Update Posted: February 5, 2020
• Sponsor: University of Pennsylvania
• Information provided by (Responsible Party): University of Pennsylvania

Study Description

Brief Summary:

The overall objective of this project is to reduce the risk of falls in elderly community dwelling women over 60 years of age with urgency urinary incontinence (UUI). In this pilot study, the investigators plan to develop, validate and test a home based integrated exercise and urge suppression intervention (bladder training) that targets functional mobility, reduces anxiety urgency and physical barriers and is implemented in partnership with all stakeholders. Key eligibility criteria: women over 60 years of age, with moderate to severe UUI, and low physical activity.

Condition or disease	Intervention/treatment	Phase
Urinary Incontinence	Other: Exercise Program	Not Applicable

Detailed Description:

Over 40% women age 65 and older or an estimated million women in the US suffer from urgency urinary incontinence (UUI), a condition characterized by urgency to urinate. UUI is a well-known marker for frailty and older women with UUI are at two fold higher risk for falls. According to the biopsycho- ecological paradigm, UUI and its associated falls are the result of interaction of the patients physical abilities (bladder urgency and reduced balance and strength to reach the toilet), mental attitudes (anxiety related to urgency, shame and stigma of leakage), social expectations (life demand and roles that limit access to bathroom), and physical environment (physical barriers to reach the toilet).

Anti-muscarinic medications, the most common treatment for UUI, address only bladder urgency and their side-effects may exacerbate falls. The investigators plan an innovative treatment approach that will integrate each of the bio-psycho-ecological levels implicated in UUI and falls. Strength and balance exercises improve functional mobility and have been shown to reduce both fall risk as well as UUI in high risk frail older adults. Behavioral urge suppression reduces anxiety related to urgency and improves mental abilities to handle life demands and roles. Simple home improvements can reduce environmental barriers. Adherence is an important barrier in the implementation of exercise and behavior modification. Prior studies, including those by the investigators, have shown that preferred treatments are associated with improved adherence, satisfaction and outcomes in women with UUI. The investigators hypothesize that an integrated exercise and urge suppression program targeted to improving physical performance relevant to continence behavior will reduce the risk of falls in appropriately selected community dwelling women with urinary incontinence. In this pilot study, the investigators plan to develop, validate and test a home based integrated exercise and urge suppression intervention that targets functional mobility, reduces anxiety urgency and physical barriers and is implemented in partnership with all stakeholders. The proposed pilot study for a planned submission in June 2014 fulfills PCORIs national priorities and research agenda through improving patient centered outcome measures, informed decision making based on risks and benefits, innovative Page 9 of 17 community based delivery of the intervention, addressing barriers to care, and engaging all stakeholders involved in the care of older women with UUI including patients, providers, and community advocates.

The overall objective of this project is to reduce the risk of falls in elderly frail community dwelling women with urgency urinary incontinence (UUI). The specific aim is: To determine the feasibility of enrollment and randomization of a comparative effectiveness trial of integrated exercise and urge suppression program versus usual care in older community dwelling women with urge urinary incontinence. Hypothesis: Older women with UUI who receive their preferred treatment option, exercises and urge suppression, will have better objective (fewer functional limitations, falls risk and urinary incontinence) and subjective (HRQOL, satisfaction with care, and psychological wellbeing) outcomes than women who receive usual care.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 37 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A pilot randomized comparative effectiveness trial of integrated exercise and urge suppression versus usual care in older women with UUI.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Comparative Effectiveness of Integrated Exercise and Urge Suppression Verses Usual Care for Reducing the Risk of Falls in Women With Urgency Urinary Incontinence
• Actual Study Start Date: March 30, 2014
• Actual Primary Completion Date: September 1, 2018
• Actual Study Completion Date: September 1, 2018

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Usual Care; Participant is assigned to undergo standard of care.
Experimental: Exercise Group; If the participant is assigned to the exercise group, she will either exercise at home or take a class at the participating facility under the supervision of an instructor.	Other: Exercise Program; Exercise at home or through a class as chosen by the subject.
No Intervention: Observational Group; If a subject is eligible, but does not want to exercise, she will be in a third group that is an observation group.

Outcome Measures

Primary Outcome Measures :

1. Physical Function as measured by the Short Physical Performance Battery [ Time Frame: 2 months ]
   An objective measure of physical function as measured by the Short Physical Performance Battery that measures balance, gait speed, and lower extremity strength and has high validity and sensitivity to change for predicting fall risk.

Eligibility Criteria

• Ages Eligible for Study: 60 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. female
2. age 60+ years
3. community dwelling
4. Moderate to severe UUI (as measured by International Consultation on Incontinence Questionnaire Short Form)
5. low physical activity (Physical Activity Staging questionnaire)
6. cognitively able to complete the study (in opinion of the referring provider) Women currently on anti-cholinergic medication for urinary incontinence will be allowed if particpants meet the above criteria.

Exclusion Criteria:

1. cognitive impairment (in opinion of the referring provider)
2. unable to provide informed consent or communicate in English
3. desire for surgical management
4. osteoporosis
5. lack of medical clearance from the physician.

Contacts and Locations

Locations

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

University of Pennsylvania

More Information

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT03869918
• Other Study ID Numbers: 819469
• First Posted: March 11, 2019
• Last Update Posted: February 5, 2020
• Last Verified: February 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Urinary Incontinence; Enuresis; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Mental Disorders