A Randomized Controlled Trial Comparing Pilates, Pilates Combined With Voluntary Pelvic Floor Muscle Contraction, and Isolated Pelvic Floor Muscle Training for the Treatment of Stress Urinary Incontinence in Women
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Federal University of Uberlandia
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Change in International Consultation on Incontinence (ICIQ-SF) total score
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Arm 1 - Pelvic floor muscle training
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.
Intervention: Pelvic Floor Muscle Training (Other)
Arm 2 - Pilates group
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.
Intervention: Pilates Exercise Program (Other)
Arm 3 - Pilates + pelvic floor contraction
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.
Intervention: Pilates With Voluntary Pelvic Floor Muscle Contraction (Other)
Outcomes
Primary Outcomes
Change in International Consultation on Incontinence (ICIQ-SF) total score
Time Frame: Baseline and 6 weeks
Difference in total score from baseline to post-intervention. Higher scores indicate worse urinary incontinence impact.
Secondary Outcomes
- Change in urinary leakage episodes (72-hour bladder diary)(Baseline and 6 weeks)
- Change in Pelvic Floor Muscle Strength (Modified Oxford Scale, 0-5)(baseline and 6 weeks)
Investigators
Ana Paula Magalhães Resende
Professor, PT, PhD
Federal University of Uberlandia