Outpatient biofeedback in addition to home pelvic floor muscle training for stress urinary incontinence: a randomized controlled trial

Abstract

Aims: To test if biofeedback (BF) added to pelvic floor muscle training (PFMT) increases the frequency of home exercises performed by women with stress urinary incontinence (SUI).

Methods: 72 incontinent women were randomized to BF (outpatient BF + home PFMT) or PFMT (outpatient PFMT + home PFMT) groups.

Assessments: baseline, after 3 months of supervised treatment, at 9-month follow-up (after six additional months of home PFMT only).

Primary outcome: frequency of monthly exercises sets performed (exercise diary) after 3-month treatment.

Secondary outcomes: adherence, urinary symptoms, severity and cure of SUI (pad test <2 g leakage), muscle function, quality of life, and subject cure (satisfaction report with no desire for different treatment) at the two time-points.

Statistical analyses: ANOVA and Student's t-test with 5% cut-off for significance.

Results: It was observed similar frequency of monthly home exercises sets performed by BF (67.9 out of 82) and PFMT (68.2 out of 82) groups at 3 months. Secondarily, equal satisfaction, but superior objective cure of SUI for BF group after 3-month treatment (P = 0.018; OR: 3.15 [95% CI: 1.20-8.25]). At 9-month follow-up, the adherence to home exercises was similar (around 50%) and significantly dropped in both groups compared to the 3-month results (around 85%). No difference was detected in the objective and subjective cure of SUI between the groups after 9 months. Both therapies similarly improved the muscle function and quality of life during the study (P < 0.005).

Conclusions: Adjunct BF did not increase the frequency of home exercises performed by SUI patients.

Keywords: exercise; patient compliance; pelvic floor; physical therapy modalities; stress; urinary incontinence.