Systematized Quality Exercise Alternatives for Stress Incontinence (SQEASI)

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Stress Urinary Incontinence; Incontinence, Urinary; Pelvic Floor; Weak
• Intervention / Treatment: Behavioral: Pelvic Floor Physical Therapy; Device: Home Biofeedback

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: Pelvic Floor Physical Therapy; Pelvic floor exercises for 3 months under instruction of physical therapist; Other Names: PFPT
Experimental: 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.	Device: Home Biofeedback; Pelvic floor exercises for 3 months using biofeedback device; Other Names: PeriCoach Kegel Exerciser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual Function	Female sexual index will be used to assess change in sexual function over study. Female sexual function index (FSFI) questionnaire and Pelvic organ prolapse incontinence sexual questionnaire were PI developed questionnaires. The minimum is 0 and the maximum is 36. A higher score indicates greater sexual impairment.	3 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction using Likert scale	Likert scale will be used to assess satisfaction with treatment arm	3 Months

Collaborators and Investigators

• Sponsor: University of New Mexico
• Investigators: Principal Investigator: Gena Dunivan, MD, University of New Mexico HSC, Department of Obstetrics and Gynecology

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): March 3, 2020
• Study Completion (Actual): March 3, 2020

Study Registration Dates

• First Submitted: February 17, 2018
• First Submitted That Met QC Criteria: February 17, 2018
• First Posted (Actual): February 23, 2018

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: SQEASI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No