Physical Exercise and Bladder Training Program for Urinary Incontinence

NCT03869918 | Completed DMC

• 1 other identifier: 819469
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Physical Function as measured by the Short Physical Performance Battery

  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.

  2 months

Study Arms (3)

Usual Care

NO INTERVENTION

Participant is assigned to undergo standard of care.

Exercise Group

EXPERIMENTAL

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

Observational Group

NO INTERVENTION

If a subject is eligible, but does not want to exercise, she will be in a third group that is an observation group.

Interventions

Exercise Program OTHER

Exercise at home or through a class as chosen by the subject.

Exercise Group

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female
• age 60+ years
• community dwelling
• Moderate to severe UUI (as measured by International Consultation on Incontinence Questionnaire Short Form)
• low physical activity (Physical Activity Staging questionnaire)
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Resistance Training

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

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A pilot randomized comparative effectiveness trial of integrated exercise and urge suppression versus usual care in older women with UUI.

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 11, 2019
• Study Start: March 30, 2014
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)