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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - Pelvic floor muscle training | Active Comparator | Intervention: Behavioral: Pelvic Floor Muscle Training Participants perform isolated pelvic floor muscle exercises in supine, sitting, and standing positions, including sustained and rapid contractions, twice weekly for 12 session. Stretching and mobility exercises are performed during rest intervals. |
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| Arm 2 - Pilates group | Experimental | Intervention: Other: Pilates Exercise Program Participants perform mat and equipment-based Pilates exercises (Reformer, Chair, Cadillac) for 6 weeks, twice weekly - 12 session. Exercises are performed in three progressive phases (8-10-12 repetitions, 3 sets). Abdominal contraction is requested during expiration to activate the "powerhouse," without voluntary pelvic floor muscle contraction instruction. |
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| Arm 3 - Pilates + pelvic floor contraction | Experimental | Intervention: Other: Pilates With Voluntary Pelvic Floor Muscle Contraction Same protocol as the Pilates group; however, participants are instructed to perform simultaneous voluntary pelvic floor muscle contraction during each expiratory phase. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic Floor Muscle Training | Other | Supervised isolated pelvic floor muscle exercises performed in supine, sitting, and standing positions, including sustained and rapid contractions, twice weekly for 12 sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in International Consultation on Incontinence (ICIQ-SF) total score | Difference in total score from baseline to post-intervention. Higher scores indicate worse urinary incontinence impact. | Baseline and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in urinary leakage episodes (72-hour bladder diary) | 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. | Baseline and 6 weeks |
| Change in Pelvic Floor Muscle Strength (Modified Oxford Scale, 0-5) |
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Inclusion Criteria:
Exclusion Criteria:
Women ≥18 years
Self-reported stress urinary incontinence
Positive response to stress-related leakage question
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Uberlandia | Uberlândia | Minas Gerais | 30400-678 | Brazil |
De-identified individual participant data underlying the results reported in publications, including baseline characteristics and outcome measures. Study protocol and statistical analysis plan will be avalilable. Data will be available upon reasonable request to the principal investigator and after approval by the institutional ethics committee.
Beginning 6 months after publication and ending 5 years after publication.
Researchers who provide a methodologically sound proposal.
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| Pilates Exercise Program | Other | 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. |
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| Pilates With Voluntary Pelvic Floor Muscle Contraction | Other | Same 12-session supervised Pilates protocol, with simultaneous voluntary pelvic floor muscle contraction during each expiratory phase. |
|
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. |
| baseline and 6 weeks |
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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