Outpatient Biofeedback in Addition to Home Pelvic Floor Muscle Exercises

Federal University of São Paulo

Status: Completed

Conditions: Urinary Incontinence, Stress

Treatments: Other: PFMT without biofeedback + Home PFMT; Other: PFMT with biofeedback + Home PFMT

Study type: Interventional

Funder types: Other

Identifiers

NCT02851719

02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

BF group

Experimental group

Description:

24 outpatient sessions of the PFMT (twice a week) using manometric-based BF equipment and daily home PFMT exercises.

Treatment:

Other: PFMT with biofeedback + Home PFMT

PFMT group

Active Comparator group

Description:

24 outpatient sessions (twice a week) of PFMT without BF and daily home PFMT exercises.

Treatment:

Other: PFMT without biofeedback + Home PFMT