Systematized Quality Exercise Alternatives for Stress Incontinence

NCT ID: NCT03443687

Last Updated: 2023-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2020-03-03

Brief Summary

This randomized controlled study evaluates the effect of home biofeedback compared to pelvic floor physical therapy for the treatment of stress urinary incontinence. Half of the participants will use a home biofeedback device for 3 months and the other half will attend pelvic floor physical therapy appointments for 3 months.

Detailed Description

Biofeedback has been shown to be highly effective the treatment of stress urinary incontinence when used in conjunction with pelvic floor physical therapy under the instruction of a healthcare provider. Home biofeedback has not been well studied, even though several FDA cleared devices are on the market and available for patients to purchase. It is unclear if the biofeedback improves women's urinary incontinence, or if the increased contact with a healthcare provider causes the improvement.

Using a home biofeedback device, a woman places the device in her vagina and contracts the muscles of her pelvic floor to improve the strength, which can improve or cure incontinence when performed over time. Typically it takes 3 months for benefit to be seen.

Conditions

Stress Urinary Incontinence; Pelvic Floor; Weak; Incontinence, Urinary; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pelvic Floor Physical Therapy

If randomized to this arm, women will complete demographic forms and questionnaires. They will then undergo the intervention of 4 pelvic floor physical therapy visits over 3 months. At that time they will return for a follow up visit and complete questionnaires.

Group Type: ACTIVE_COMPARATOR

Pelvic Floor Physical Therapy

Intervention Type: BEHAVIORAL

Pelvic floor exercises for 3 months under instruction of physical therapist

Home Biofeedback

If randomized to this arm, women will complete demographic forms and questionnaires. They will then be given a pelvic floor exercise device that is bluetooth linked to a smartphone application. They will be instructed on how to use the device daily for 3 months and their intervention will be to perform daily exercises with the device in place. At 3 months they will return for a follow up visit and complete questionnaires.

Group Type: EXPERIMENTAL

Home Biofeedback

Intervention Type: DEVICE

Pelvic floor exercises for 3 months using biofeedback device

Interventions

Pelvic Floor Physical Therapy

Pelvic floor exercises for 3 months under instruction of physical therapist

Intervention Type: BEHAVIORAL

Home Biofeedback

Pelvic floor exercises for 3 months using biofeedback device

Intervention Type: DEVICE

Other Intervention Names

PFPT; PeriCoach Kegel Exerciser

Eligibility Criteria

Inclusion Criteria

• Female Subjects >18 years of age
• SUI or Mixed UI with stress predominant symptoms and more bother by the SUI
• English speaking/reading
• Own a smartphone that can support phone application and Bluetooth for the biofeedback device
• Willing to come for 4 PFPT visits over 3 months if randomized

Exclusion Criteria

• Prior anti-incontinence surgery
• Had prior pelvic floor physical therapy for SUI
• Prolapse of any compartment noted below the hymen
• Inability to speak/understand English
• Pregnant
• Decline or unable to return for frequent PT visits during study period
• Unable to be contacted for follow up by telephone
• Neurologic disorders known to cause neurogenic bladder

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of New Mexico

OTHER

Sponsor Role: lead

Responsible Party

Gena Dunivan

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gena Dunivan, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico HSC, Department of Obstetrics and Gynecology

Locations

University of New Mexico

Albuquerque, New Mexico, United States

Countries

United States

References

Barnes KL, Cichowski S, Komesu YM, Jeppson PC, McGuire B, Ninivaggio CS, Dunivan GC. Home Biofeedback Versus Physical Therapy for Stress Urinary Incontinence: A Randomized Trial. Female Pelvic Med Reconstr Surg. 2021 Oct 1;27(10):587-594. doi: 10.1097/SPV.0000000000000993.

Reference Type: DERIVED

PMID: 33208658 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

SQEASI

Identifier Type: -

Identifier Source: org_study_id