PFMT PUMCH
Trial question
What is the role of pressure-mediated biofeedback with pelvic floor muscle training in patients with stress urinary incontinence?
Study design
Multi-center
Open label
RCT
Population
452 female patients.
Inclusion criteria: women with new-onset postpartum stress urinary incontinence.
Key exclusion criteria: urgency urinary incontinence alone; third- or fourth-degree perineal tears; diastasis recti abdominis and chronic pelvic pain; pre-pregnancy stress urinary incontinence; previous pelvic surgery; malignant pelvic cancer; urogenital infections; inability to contract the pelvic floor muscle.
Interventions
N=223 PFMT with biofeedback (pelvic floor muscle training performed at home with a home-based pressure-mediated biofeedback device).
N=229 PFMT (pelvic floor muscle training performed at home).
Primary outcome
Median reduction in urinary incontinence evaluated by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form total score at 3 months
3 points
2 points
3.0 points
2.3 points
1.5 points
0.8 points
0.0 points
PFMT with
biofeedback
PFMT
Significant
increase ▲
Significantly greater reduction in median urinary incontinence evaluated by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form total score at 3 months (3 points vs. 2 points; AD 1 points, 95% CI 0.37 to 1.63).
Secondary outcomes
Significant increase in cure rate of stress urinary incontinence (20.2% vs. 8.7%; AD 11.5%, 95% CI 4.68 to 18.32).
Significant increase in improvement rate of stress urinary incontinence (59.2% vs. 44.5%; AD 14.7%, 95% CI 5.4 to 24).
Significant increase in median pelvic floor muscle strength at 3 months (26 cmH20 vs. 21 cmH20; AD 5 cmH20, 95% CI 0.78 to 9.22).
Conclusion
In women with new-onset postpartum stress urinary incontinence, PFMT with biofeedback was superior to PFMT with respect to median reduction in urinary incontinence evaluated by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form total score at 3 months.
Reference
Xiuqi Wang, Jin Qiu, Dan Li et al. Pressure-Mediated Biofeedback With Pelvic Floor Muscle Training for Urinary Incontinence: A Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2442925.
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