Outpatient Biofeedback in Addition to Home Pelvic Floor Muscle Exercises

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Urinary Incontinence, Stress

Intervention / Treatment
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* Other: PFMT with biofeedback + Home PFMT
* Other: PFMT without biofeedback + Home PFMT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BF group<br>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<br>* 24 outpatient sessions PFMT with biofeedback (twice a week). Simultaneously, it was prescribed a home exercise daily program during three months (supervised treatment).<br>* Other names: Biofeedback;|
| Active Comparator: PFMT group<br>24 outpatient sessions (twice a week) of PFMT without BF and daily home PFMT exercises. | Other: PFMT without biofeedback + Home PFMT<br>* 24 outpatient sessions PFMT without biofeedback (twice a week). Simultaneously, it was prescribed a home exercise daily program during three months (supervised treatment).<br>* Other names: PFMT alone;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary Incontinence, Stress, Pelvic Floor, Exercise, Patient Compliance