NCT03058042

Outpatient and Home Pelvic Floor Training for Stress Urinary Incontinence

Outpatient Pelvic Floor Muscle Training Versus Home Pelvic Floor Muscle Training for Stress Urinary Incontinence: Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to compare the effect of outpatient pelvic floor muscle training versus home pelvic floor muscle training in the treatment of stress urinary incontinence. The hypothesis of this study is that home pelvic floor muscle training is as effective as outpatient pelvic floor muscle training for the treatment of stress urinary incontinence.

Detailed description

Success with the pelvic floor muscle training (PFMT) is hampered by non-adherence, which is related to factors such as inability to contract the pelvic floor muscles and lack of motivation. Thus under supervision by a physiotherapist (outpatient training), PFMT has the potential of improving adherence to training and has been demonstrated to be more effective when compared to unsupervised PFMT (home training). The objective of this study is to compare the effect of outpatient pelvic floor muscle training versus home pelvic floor muscle training in the treatment of stress urinary incontinence. This is a randomized controlled trial and which will be conducted at the Division of Urogynecology and Reconstructive Pelvic Surgery at the Federal University of Sao Paulo, Brazil. As a primary endpoint, the standardized volume test pad (250 mL) will be used. To assert that one of the groups (home PFMT or outpatient PFMT) is superior to the other, it will be necessary to find 38.5% more patients cured when the groups are compared. Secondary outcome measures will be used, assessment of the pelvic floor muscles function, urinary symptoms, quality of life and subjective cure.

Conditions

• Urinary Incontinence, Stress

Interventions

Type	Name	Description
OTHER	Exercises of the pelvic floor muscle at home	Patients will perform pelvic floor exercises at home.
OTHER	Exercises of the pelvic floor muscle in the outpatient	Patients will perform pelvic floor exercises in the outpatient.

Timeline

• Start date: 2017-07-01
• Primary completion: 2017-12-30
• Completion: 2017-12-30
• First posted: 2017-02-20
• Last updated: 2018-02-07

Locations

1 site across 1 country: Brazil