Outpatient Biofeedback in Addition to Home Pelvic Floor Muscle Exercises

Outpatient Biofeedback in Addition to Home Pelvic Floor Muscle Training for Stress Urinary Incontinence: a Randomized Controlled Trial

To test whether biofeedback (BF) added to pelvic floor muscle training (PFMT) promotes additional benefits over PFMT alone in the stress urinary incontinence (SUI) treatment.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence, Stress
• Intervention / Treatment: Other: PFMT with biofeedback + Home PFMT; Other: PFMT without biofeedback + Home PFMT

Detailed Description

Introduction: The aim of this study was to test the hypothesis that outpatient BF added to home PFMT results in increased frequency of home exercises sets per month performed by the patients and objective cure rate after 3 months of supervised training. Secondarily, to investigate other subjective and objective clinical parameters in the groups that received or not BF together with PFMT after 3 months of supervised training, and in a longer term of 9-month follow-up.

Method: 72 incontinent women were randomized to the: BF Group (outpatient BF + home PFMT) or PFMT Group (outpatient PFMT + home PFMT).

Assessments: baseline after 3 months of supervised treatment and at 9-month follow-up (after 6 additional months of home PFMT without supervision).

Primary outcomes: adherence - monthly exercises sets performed (exercise diary) and objective cure of SUI (pad test) after 3 months.

Secondary outcomes: urinary symptoms, muscle function, quality of life, adhesion and subject cure at the two time-points.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• SUI and mixed urinary incontinence with predominant symptoms of SUI with ≥ 2 g of leakage measured by pad test

Exclusion Criteria:

• younger than 18 years old
• chronic degenerative diseases
• pelvic organ prolapse greater than stage I by POP-Q
• neurologic or psychiatric diseases
• previously undergone pelvic floor re-education programs and/or previous pelvic floor surgeries

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
Experimental: BF group; 24 outpatient sessions of the PFMT (twice a week) using manometric-based BF equipment and daily home PFMT exercises.	Other: PFMT with biofeedback + Home PFMT; 24 outpatient sessions PFMT with biofeedback (twice a week). Simultaneously, it was prescribed a home exercise daily program during three months (supervised treatment).; Other Names: Biofeedback
Active Comparator: PFMT group; 24 outpatient sessions (twice a week) of PFMT without BF and daily home PFMT exercises.	Other: PFMT without biofeedback + Home PFMT; 24 outpatient sessions PFMT without biofeedback (twice a week). Simultaneously, it was prescribed a home exercise daily program during three months (supervised treatment).; Other Names: PFMT alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pad test	To quantify the severity of SUI and as the tool to estimate objective cure rate	Baseline, after 3 months of supervised treatment and at 9-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 7-Day Voiding Diary	To assess the loss efforts	Baseline, after 3 months of supervised treatment and at 9-month follow-up
Change in pelvic floor muscle function (Oxford Grading Scale)	To assess the function of the pelvic floor muscle	Baseline, after 3 months of supervised treatment and at 9-month follow-up
Change in pelvic floor muscle function (Peritron manometer)	To assess the function of the pelvic floor muscle	Baseline, after 3 months of supervised treatment and at 9-month follow-up
Change in Incontinence Quality-of-Life Questionnaire (I-QoL)	To quantify the impact of SUI on quality of life	Baseline, after 3 months of supervised treatment and at 9-month follow-up
Subjective cure of SUI ("satisfied" or "dissatisfied")	To evaluate the patient satisfaction with treatment	After 3 months of supervised treatment and at 9-month follow-up
Frequency and adhesion to the home exercises	The weekly frequency (days/week that patients performed at least 1 set of exercises) and the number of sets per day	After 3 months of supervised treatment and at 9-month follow-up
Frequency of the outpatient sessions	The frequency of the outpatient sessions was monitored	After 3 months of supervised treatment

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico
• Investigators: Principal Investigator: Fatima F Fitz, M.Sc, Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: July 28, 2016
• First Submitted That Met QC Criteria: July 28, 2016
• First Posted (Estimate): August 2, 2016

Study Record Updates

• Last Update Posted (Estimate): August 3, 2016
• Last Update Submitted That Met QC Criteria: August 1, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Exercise; Urinary Incontinence, Stress; Patient Compliance; Pelvic Floor
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The individual participant data (IPD) collected in this study are being analyzed by the researchers to be available.