Stress Urinary Incontinence (SUI)
Conditions
Brief summary
This assessor-blinded randomized controlled trial aims to compare the effectiveness of three exercise programs for the treatment of stress urinary incontinence (SUI) in women: (1) Pilates without voluntary pelvic floor muscle contraction, (2) Pilates combined with voluntary pelvic floor muscle contraction, and (3) isolated pelvic floor muscle training (PFMT). Seventy-eight women aged over 18 years with self-reported SUI are randomly allocated into three parallel groups. Interventions last 6 weeks, with two sessions per week (12 sessions). The primary outcome is the change in the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) score from baseline to post-intervention. Secondary outcomes include urinary frequency and leakage episodes (72-hour bladder diary), pelvic floor muscle strength (Modified Oxford Scale), endurance, rapid contractions, and vaginal squeeze pressure measured by perineal manometry (Peritron). The hypothesis is that Pilates combined with voluntary pelvic floor muscle contraction will be superior to Pilates alone and comparable or superior to isolated PFMT.
Interventions
Supervised isolated pelvic floor muscle exercises performed in supine, sitting, and standing positions, including sustained and rapid contractions, twice weekly for 12 sessions.
12-session supervised Pilates program including mat and apparatus exercises (Reformer, Chair, Cadillac), performed twice weekly. Abdominal activation during expiration is required, without voluntary pelvic floor muscle contraction instruction.
Same 12-session supervised Pilates protocol, with simultaneous voluntary pelvic floor muscle contraction during each expiratory phase.
Sponsors
Study design
Eligibility
Inclusion criteria
* Women ≥18 years * Self-reported stress urinary incontinence * Positive response to stress-related leakage question
Exclusion criteria
* Inability to read/respond to questionnaires * Urinary tract infection within last 2 weeks * Current smoking * Previous pelvic surgery (except cesarean section) * Previous pelvic radiotherapy * Neurological disease * Pelvic floor muscle strength grade 0-1 (Modified Oxford Scale) * Pregnancy or \<3 months postpartum
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in International Consultation on Incontinence (ICIQ-SF) total score | Baseline and 6 weeks | Difference in total score from baseline to post-intervention. Higher scores indicate worse urinary incontinence impact. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in urinary leakage episodes (72-hour bladder diary) | Baseline and 6 weeks | Change from baseline to 12 weeks in the number of urinary leakage episodes recorded in a 72-hour bladder diary. Higher values indicate worse symptom severity. |
| Change in Pelvic Floor Muscle Strength (Modified Oxford Scale, 0-5) | baseline and 6 weeks | Change from baseline to12 session in pelvic floor muscle strength measured using the Modified Oxford Scale (0 = no contraction; 5 = strong contraction with lift toward the pubic symphysis). Higher scores indicate greater muscle strength. |
Countries
Brazil