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
- Are there results?
- None posted in the registry
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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07421531
- Acronym / sponsor ID
- 88644825.5.0000.5152
- Conditions
- Stress Urinary Incontinence (SUI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 29 Nov 2025 (actual)
- Study completion
- 29 Nov 2025 (actual)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Pelvic floor muscle training | Active comparator | Other: Pelvic Floor Muscle TrainingIntervention: 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. |
| Arm 2 - Pilates group | Experimental | Other: Pilates Exercise ProgramIntervention: 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. |
| Arm 3 - Pilates + pelvic floor contraction | Experimental | Other: Pilates With Voluntary Pelvic Floor Muscle ContractionIntervention: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women ≥18 years
- Self-reported stress urinary incontinence
- Positive response to stress-related leakage question
Key exclusion criteria (8 listed)
- Inability to read/respond to questionnaires
- Urinary tract infection within last 2 weeks
- Current smoking
- Previous pelvic surgery (except cesarean section)
- Previous pelvic radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic Floor Muscle TrainingSupervised isolated pelvic floor muscle exercises performed in supine, sitting, and standing positions, including sustained and rapid contractions, twice weekly for 12 sessions. | Other | Arm 1 - Pelvic floor muscle training |
| Pilates Exercise Program12-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. | Other | Arm 2 - Pilates group |
| Pilates With Voluntary Pelvic Floor Muscle ContractionSame 12-session supervised Pilates protocol, with simultaneous voluntary pelvic floor muscle contraction during each expiratory phase. | Other | Arm 3 - Pilates + pelvic floor contraction |
Primary outcome
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.
2 secondary outcomes
Change in urinary leakage episodes (72-hour bladder diary)
Time frame: Baseline and 6 weeks
Change in Pelvic Floor Muscle Strength (Modified Oxford Scale, 0-5)
Time frame: baseline and 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in International Consultation on Incontinence (ICIQ-SF) total score (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.