Is Electromyographic Biofeedback Plus Pelvic Floor Muscle Training Beneficial in Women with Urinary Incontinence?

9 Feb, 21

Introduction

Regular and progressive pelvic floor muscle training (PFMT) for three months improves pelvic floor muscle function and is currently recommended for stress and mixed urinary incontinence. Electromyographic biofeedback is used as an adjunct to PFMT. It uses a vaginal probe to capture the electrical activity of the pelvic floor muscles, which is displayed on a screen and allows women to visualize the activity of their pelvic floor muscles while exercising, thereby motivating them and increasing the adherence to the prescribed exercises.

Aim

This study compares the effectiveness of PFMT plus electromyographic biofeedback or PFMT alone for stress or mixed urinary incontinence in women.

Method

Study Design

Multicenter, parallel-group randomized controlled trial.

Treatment Strategy

This study was conducted across 23 community and secondary care centers providing continence care in Scotland and England.
A total of 600 women aged >18 years, newly presenting with clinically diagnosed stress or mixed urinary incontinence were randomized to PFMT plus electromyographic biofeedback and PFMT alone.
The cohort was offered six face-to-face appointments with a continence therapist over 16 weeks.
The therapist evaluated the pelvic floor muscles, taught the correct technique for exercise and prescribed an individualized PFMT program to be followed at home.
Electromyographic feedback was integrated with PFMT for the participants in the biofeedback PFMT group.

Endpoints

Primary Endpoint

Severity of urinary incontinence (International Consultation on Incontinence Questionnaire-urinary incontinence short form (ICIQ-UI SF) at 24 months. The score ranges from 0 to 21, with higher scores indicating greater severity.

Secondary Endpoints

Cure and improvement in urinary incontinence and other pelvic floor symptoms
Condition specific quality of life
Women’s perception of improvement
PFMT self-efficacy
Intervention costs
Quality adjusted life years
Adverse events (AEs)

Results

There was no statistically significant difference in the mean ICIQ-UI SF scores at 24 months 8.2 (SD 5.1, n=225) in the biofeedback PFMT group vs 8.5 (SD 4.9, n=235) in the PFMT group (mean difference −0.09, p=0.84).
These findings remained in subgroup analyses irrespective of urinary incontinence type, age, severity, or therapist type
Across all secondary urinary outcomes (cure or improvement, other lower urinary tract symptoms, condition specific quality of life, patient perception of urinary incontinence improvement) at the 24 month follow-up, a consistent pattern of no difference between groups was observed
The proportion of women with cure and improvement as well patients’ perception of improvement is shown in Table 1.

Table 1. Cure and Improvement at 24 months

	Biofeedback PFMT	PFMT alone	Odds ratio	P value
% women with cure at 24 months	7.9%	8.4%	0.9	0.77
% women with improvement at 24 months	60%	62.6%	0.89	0.57
% women who reported that symptoms were ‘very much better’ or ‘much better’	41%	38.1%	1.12	0.57

A significant difference was observed in the overall score for PFMT favoured biofeedback PFMT group; mean 63.1 vs 60.9; mean difference 2.36; p=0.05
The findings of the economic analysis suggest that both interventions resulted in similar overall costs and quality of life over the follow-up period.
AEs were reported by 48 participants (34 biofeedback PFMT, 14 PFMT), of whom 23 (21 biofeedback PFMT, 2 PFMT) had an event related or possibly related to the trial interventions.

Conclusion

This study did not demonstrate any clinically significant benefits in the severity of urinary incontinence at 24 months between women randomized to electromyographic biofeedback pelvic floor muscle training (PFMT) or to PFMT alone.
Routine use of electromyographic biofeedback with PFMT for women with stress or mixed urinary incontinence should not be recommended as it did not confer any additional benefit.

BMJ. 2020 Oct; 371:m3719.