NCT02851719

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Urinary Incontinence, Stress

Interventions

Type	Name	Description
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	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).

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-03-01
• Completion: 2014-09-01
• First posted: 2016-08-02
• Last updated: 2016-08-03