Stress Urinary Incontinence (SUI)NCT07421531
Effects of Pilates With and Without Voluntary Pelvic Floor Muscle Contraction Compared to Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence
A study testing Pelvic Floor Muscle Training, Pilates Exercise Program and Pilates With Voluntary Pelvic Floor Muscle Contraction in people with Stress Urinary Incontinence (SUI), run by Federal University of Uberlandia at 1 site in Brazil.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence (SUI)
- What is being tested?
- Pelvic Floor Muscle Training, Pilates Exercise Program and Pilates With Voluntary Pelvic Floor Muscle Contraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Mar 2022to 29 Nov 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women ≥18 years
- Self-reported stress urinary incontinence
- Positive response to stress-related leakage question
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Uberlandia
Uberlândia, Minas Gerais, 30400-678
About this study
Official title: 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
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).
Read more
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.
- Conditions
- Stress Urinary Incontinence (SUI)
- Being tested
- Pelvic Floor Muscle Training, Pilates Exercise Program, Pilates With Voluntary Pelvic Floor Muscle Contraction
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor Muscle TrainingOther
Supervised isolated pelvic floor muscle exercises performed in supine, sitting, and standing positions, including sustained and rapid contractions, twice weekly for 12 sessions.
Pilates Exercise ProgramOther
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.
Pilates With Voluntary Pelvic Floor Muscle ContractionOther
Same 12-session supervised Pilates protocol, with simultaneous voluntary pelvic floor muscle contraction during each expiratory phase.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Pelvic Floor Muscle Training |
| 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. Receives: Other: Pilates Exercise Program |
| 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. Receives: Other: Pilates With Voluntary Pelvic Floor Muscle Contraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 weeks
Secondary outcomes (2)
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.
Measured: Baseline and 6 weeks
Change in Pelvic Floor Muscle Strength (Modified Oxford Scale, 0-5)
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.
Measured: baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start7 Mar 2022
- Primary completion29 Nov 2025
- Study completion29 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary Incontinence (SUI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Paula Magalhães Resende, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421531
- Sponsor's protocol ID
- 88644825.5.0000.5152
- Status last verified
- Dec 2024
- First submitted
- 12 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.