Systematized Quality Exercise Alternatives for Stress Incontinence

NCT03443687 | Completed Results FDA Device

• 1 other identifier: SQEASI
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in Quality of Life

  Scale is International Consultation Incontinence Questionnaire short form (ICIQ-SF). Minimum is 0 and Maximum is 21. A higher score indicates greater impairment from incontinence.

  3 months

Secondary Outcomes (1)

• Sexual Function

  3 Months

Study Arms (2)

Pelvic Floor Physical Therapy

ACTIVE COMPARATOR

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.

Behavioral: Pelvic Floor Physical Therapy

Home Biofeedback

EXPERIMENTAL

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.

Device: Home Biofeedback

Interventions

Pelvic Floor Physical Therapy BEHAVIORAL

Pelvic floor exercises for 3 months under instruction of physical therapist

Also known as: PFPT

Pelvic Floor Physical Therapy

Home Biofeedback DEVICE

Pelvic floor exercises for 3 months using biofeedback device

Also known as: PeriCoach Kegel Exerciser

Home Biofeedback

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: We will only recruit natal females who have stress urinary incontinence as device designed for females.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (1)

• 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.

  PMID: 33208658 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress; Asthenia; Urinary Incontinence

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

Results Point of Contact

• Title: Dr. Gena Dunivan
• Organization: University of New Mexico, Dept OBGYN

gdunivan@salud.unm.edu

5052729712

Study Officials

• Gena Dunivan, MD

  University of New Mexico HSC, Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomized to either Pelvic Floor Physical Therapy (PFPT) or home biofeedback. The therapy allocation will then be carried out with each arm completing 3 months of therapy.

Study Record Dates

• First Submitted: February 17, 2018
• First Posted: February 23, 2018
• Study Start: June 1, 2018
• Primary Completion: March 3, 2020
• Study Completion: March 3, 2020
• Last Updated: December 21, 2023
• Results First Posted: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)