Urinary Incontinence , StressNCT07212478
Pelvic Floor Muscle Training vs. Pilates Exercises for Urinary Incontinence
A study testing PFMT and Pilates exercises in people with Urinary Incontinence , Stress, run by Universidade Estadual do Norte do Parana at 1 site in Brazil.
Trial summary
Urinary incontinence (UI) affects approximately 40% of postmenopausal women and is therefore considered a public health problem. Conservative treatment is recommended, and pelvic floor muscle training (PFMT) is considered the gold standard for this condition. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women only
- Conditions the study is for
- Urinary Incontinence , Stress
- What is being tested?
- PFMT and Pilates exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Sep 2025to 10 Jan 2026
- 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 50 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being naturally post-menopause (at least one year without menstruating);
- Demonstrate independence to carry out activities of daily living;
- Have a report of urinary loss when performing physical exertion.
Who cannot join
- Women who have had hysterectomy or oophorectomy surgery;
- Women who underwent cancer treatment with hormone therapy;
- Present cognitive deficits or neurological diseases;
- Practice any type of physical activity regularly in the last six months; Present inability to hire PFM (Oxford Scale < 1);
- Report pain or discomfort in the vulva or vagina;
- Present dyspareunia, vaginismus or pelvic organ prolapse greater than grade II in the Baden-Walker classification;
- Present symptoms of urinary infection at the time of evaluation;
- Have participated in previous pelvic floor reeducation programs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Pelvic Floor Muscle Training and Pilates Exercises for Postmenopausal Women With Urinary Incontinence
Urinary incontinence (UI) affects approximately 40% of postmenopausal women and is therefore considered a public health problem. Conservative treatment is recommended, and pelvic floor muscle training (PFMT) is considered the gold standard for this condition.
However, other exercise options have been studied, such as Pilates exercises, which focus on stabilizing muscles and require voluntary contraction of the pelvic floor muscles. The literature remains inconclusive regarding the effects of Pilates exercises on urinary incontinence and pelvic floor muscle function. Objective: To compare the effects of 3 months of muscle training, through PFMT and Pilates exercises, on improving UI in postmenopausal women. Methods: Twenty-four postmenopausal women with urinary incontinence will be randomized into two intervention groups: pelvic floor muscle training and mat Pilates exercises. Assessments will be conducted before and after three months of intervention and will include the following instruments: urinary incontinence and quality of life, assessed using the International Consultation of Urinary Incontinence Short Form (ICIQ-UI-SF) questionnaire; a 7-day voiding diary to identify potential modifiable factors related to urination and its frequency; the Female Sexual Function Index to assess female sexual function; and pelvic floor muscle strength and endurance by bidigital palpation using the PERFECT test. Shapiro-Wilk tests will be used to assess normality, Student's t-test or Mann-Whitney U test according to parametric or nonparametric distribution, and ANCOVA will be used to compare groups post-intervention, considering a 95% confidence interval (p<0.05). Data will be processed using SPSS 25.0.
Read the detailed description
The sample will consist of 24 postmenopausal women, that is, who have not menstruated for at least one year and are between 50 and 70 years of age. The sample size was determined by a sample calculation performed in the Bioestat 5.3 program, taking into account the values of the ICIQ_SF (International Consultation on Incontinence Questionnaire - Short Form) instrument, made available in a previous study. In this case, the post-intervention mean and standard deviation between the Pilates (8.71 ± 2.98) and PFMT (5.14 ± 2.73) groups were used, with the test power at 80% and an alpha value of 0.05, which generated the need for 10 participants in each group. To account for potential sample losses, 15% of participants were added to each of the two groups, totaling 12 women in each group.
Descriptive data analysis will be expressed as mean, standard deviation, and delta percentage difference. Normality will be verified using the Shapiro-Wilk test. To assess for differences between groups regarding baseline characteristics (age, weight, height, and BMI) at the pre-intervention stage, the Student's t-test for independent samples or the Mann-Whitney U test will be used if the data present a parametric or nonparametric distribution, respectively. For comparison between groups post-intervention, ANCOVA will be used, with baseline data used as covariates. If the data present nonparametric characteristics, the comparison between groups will be made using the Mann-Whitney U test, considering the difference between pre- and post-intervention. The accepted confidence interval will be 95% (p<0.05). Data will be processed using SPSS 25.0. Effect sizes (Cohen's d) will be calculated and considered small (0.20), medium (0.50), or large (0.80). For effect size calculations, the GPower 3.1 program (Franz Faul, Universitat Kiel, Germany) will be used.
- Conditions
- Urinary Incontinence , Stress
- Being tested
- PFMT, Pilates exercises
- Keywords
- Post-menopause; Pilates; Muscle training of pelvic floor
- 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.
PFMTOther
O PFMT consistirá em 10 contrações voluntárias máximas que devem ser mantidas por pelo menos 6 segundos. Os participantes serão incentivados a sustentar a contração máxima por um tempo maior a cada semana. O intervalo entre as contrações será de segundos. Os participantes realizarão 4 séries de 10 contrações e, ao final de cada série de 10 contrações, serão realizadas cinco contrações rápidas. Cada série será realizada em uma posição: deitado em decúbito lateral; sentado; de quatro apoios e em pé.
Pilates exercisesOther
The Pilates group will perform 10 solo exercises, containing stretching and strengthening for the main muscle groups, with a single series of 10 repetitions.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Floor Muscle Training | Active comparator | Active Comparator: Pelvic floor muscle training (PFMT) For the intervention of the PFMT group, which is noninvasive, a physical therapist experienced in this type of training will carry out the sessions, which will be individualized, in a specific room for care ocused on pelvic physiotherapy, with a stretcher, air conditioning and a lock on the door, for the patient to feel safe. Receives: Other: PFMT |
| Pilates exercises (PE) | Experimental | For the Pilates group intervention, in the first week, the protocol will be used to familiarize participants with the exercises, demonstrating the correct execution of the movements and explaining each principle of the method: concentration, centering, precision, breathing, control, and fluidity. Ten Pilates mat exercises will be performed: 1- Rolling; 2- Swan; 3- Forward Leg Pull; 4- Bridge; 5- Hundred; 6- Crossover; 7-Wall Slide; 8- Side Kick: Inner Thigh Raise; 9- Arms Forward; 10- Forward Spine Stretch. Receives: Other: Pilates exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voiding diary
Identifies the frequency of urinary leakage. The participant will record, over the course of 7 days, at home, the number of episodes of urinary leakage during some effort, such as coughing, sneezing or jumping. If there are more than 3 urinary losses within a 7-day interval, the test is positive for UI.
Measured: 12 weeks
International Consultation of Urinary questionnaire Incontinence Short Form (ICIQ-UI-SF)
Specific quality of life questionnaire for each aspect related to UI. It consists of four questions; the sum of the first three questions gives the score, and the fourth describes the type of UI. The maximum total score is 21, and the higher the score, the worse the UI severity and disorder.
Measured: 12 weeks
PERFECT test
As a complement to the manometric evaluation, bidigital palpation will be performed. The PFM strength and resistance level will be classified using the modified Oxford scale, where 0 is the absence of muscle strength and 5 means a strong contraction with movement correct "squeeze" and "suction". Participants will attempt maximum contractions in terms of strength and endurance three times, with 30-second rest intervals between contractions. The closer to a score of 5, the better the MAP.
Measured: 12 weeks
FSFI Questionnaire (Female Sexual Function Index)
To assess women's sexual function, the domains: desire, arousal, lubrication, orgasm, satisfaction and pain are used. It has 19 items. Each question presents a possibility of response with a pattern from 0 to 5, where at the end you can have the result of the scores of each domain and also of the total score, where values below or equal to 26.55 indicate sexual dysfunction.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start30 Sep 2025
- Primary completion10 Jan 2026
- Study completion10 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence , StressStudies 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
- Model description
- The interventions will last twelve weeks, twice a week, for one hour, on alternating days. 1. The pelvic floor muscle training group protocol will consist of four sets of ten maximal contractions, held for at least six seconds, followed by five rapid contractions at the end of each set. Each set will be performed in a different position: first lying on your side, second sitting, third on all fours, and fourth standing. 2. The Pilates exercise group protocol will consist of 10 exercises, four specific to stretching and six for muscle strengthening.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual do Norte do Parana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laís Campos de Oliveira, Universidade Estadual do Norte do Parana
- Investigators
- Laís Campos de Oliveira, PhD, Principal investigator, Universidade Estadual do Norte do Paraná
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212478
- Sponsor's protocol ID
- 5.264.703
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Pelvic Floor Muscle Training and Pilates Exercises for Postmenopausal Women With Urinary Incontinence
- ClinicalTrials.gov ID
- NCT07212478
- Acronym / sponsor ID
- 5.264.703
- Conditions
- Urinary Incontinence , Stress
- Keywords
- Post-menopause; Pilates; Muscle training of pelvic floor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universidade Estadual do Norte do ParanaUniversity, hospital or other
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 10 Jan 2026 (actual)
- Study completion
- 10 Jan 2026 (actual)
- First posted
- 8 Oct 2025 (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.
Urinary incontinence (UI) affects approximately 40% of postmenopausal women and is therefore considered a public health problem. Conservative treatment is recommended, and pelvic floor muscle training (PFMT) is considered the gold standard for this condition.
However, other exercise options have been studied, such as Pilates exercises, which focus on stabilizing muscles and require voluntary contraction of the pelvic floor muscles. The literature remains inconclusive regarding the effects of Pilates exercises on urinary incontinence and pelvic floor muscle function. Objective: To compare the effects of 3 months of muscle training, through PFMT and Pilates exercises, on improving UI in postmenopausal women. Methods: Twenty-four postmenopausal women with urinary incontinence will be randomized into two intervention groups: pelvic floor muscle training and mat Pilates exercises. Assessments will be conducted before and after three months of intervention and will include the following instruments: urinary incontinence and quality of life, assessed using the International Consultation of Urinary Incontinence Short Form (ICIQ-UI-SF) questionnaire; a 7-day voiding diary to identify potential modifiable factors related to urination and its frequency; the Female Sexual Function Index to assess female sexual function; and pelvic floor muscle strength and endurance by bidigital palpation using the PERFECT test. Shapiro-Wilk tests will be used to assess normality, Student's t-test or Mann-Whitney U test according to parametric or nonparametric distribution, and ANCOVA will be used to compare groups post-intervention, considering a 95% confidence interval (p<0.05). Data will be processed using SPSS 25.0.
Detailed description
The sample will consist of 24 postmenopausal women, that is, who have not menstruated for at least one year and are between 50 and 70 years of age. The sample size was determined by a sample calculation performed in the Bioestat 5.3 program, taking into account the values of the ICIQ_SF (International Consultation on Incontinence Questionnaire - Short Form) instrument, made available in a previous study. In this case, the post-intervention mean and standard deviation between the Pilates (8.71 ± 2.98) and PFMT (5.14 ± 2.73) groups were used, with the test power at 80% and an alpha value of 0.05, which generated the need for 10 participants in each group. To account for potential sample losses, 15% of participants were added to each of the two groups, totaling 12 women in each group.
Descriptive data analysis will be expressed as mean, standard deviation, and delta percentage difference. Normality will be verified using the Shapiro-Wilk test. To assess for differences between groups regarding baseline characteristics (age, weight, height, and BMI) at the pre-intervention stage, the Student's t-test for independent samples or the Mann-Whitney U test will be used if the data present a parametric or nonparametric distribution, respectively. For comparison between groups post-intervention, ANCOVA will be used, with baseline data used as covariates. If the data present nonparametric characteristics, the comparison between groups will be made using the Mann-Whitney U test, considering the difference between pre- and post-intervention. The accepted confidence interval will be 95% (p<0.05). Data will be processed using SPSS 25.0. Effect sizes (Cohen's d) will be calculated and considered small (0.20), medium (0.50), or large (0.80). For effect size calculations, the GPower 3.1 program (Franz Faul, Universitat Kiel, Germany) will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The interventions will last twelve weeks, twice a week, for one hour, on alternating days. 1. The pelvic floor muscle training group protocol will consist of four sets of ten maximal contractions, held for at least six seconds, followed by five rapid contractions at the end of each set. Each set will be performed in a different position: first lying on your side, second sitting, third on all fours, and fourth standing. 2. The Pilates exercise group protocol will consist of 10 exercises, four specific to stretching and six for muscle strengthening.
| Arm | Type | Receives |
|---|---|---|
| Pelvic Floor Muscle Training | Active comparator | Other: PFMTActive Comparator: Pelvic floor muscle training (PFMT) For the intervention of the PFMT group, which is noninvasive, a physical therapist experienced in this type of training will carry out the sessions, which will be individualized, in a specific room for care ocused on pelvic physiotherapy, with a stretcher, air conditioning and a lock on the door, for the patient to feel safe. |
| Pilates exercises (PE) | Experimental | Other: Pilates exercisesFor the Pilates group intervention, in the first week, the protocol will be used to familiarize participants with the exercises, demonstrating the correct execution of the movements and explaining each principle of the method: concentration, centering, precision, breathing, control, and fluidity. Ten Pilates mat exercises will be performed: 1- Rolling; 2- Swan; 3- Forward Leg Pull; 4- Bridge; 5- Hundred; 6- Crossover; 7-Wall Slide; 8- Side Kick: Inner Thigh Raise; 9- Arms Forward; 10- Forward Spine Stretch. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being naturally post-menopause (at least one year without menstruating);
- Demonstrate independence to carry out activities of daily living;
- Have a report of urinary loss when performing physical exertion.
Key exclusion criteria (8 listed)
- Women who have had hysterectomy or oophorectomy surgery;
- Women who underwent cancer treatment with hormone therapy;
- Present cognitive deficits or neurological diseases;
- Practice any type of physical activity regularly in the last six months; Present inability to hire PFM (Oxford Scale < 1);
- Report pain or discomfort in the vulva or vagina;
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 |
|---|---|---|
| PFMTO PFMT consistirá em 10 contrações voluntárias máximas que devem ser mantidas por pelo menos 6 segundos. Os participantes serão incentivados a sustentar a contração máxima por um tempo maior a cada semana. O intervalo entre as contrações será de segundos. Os participantes realizarão 4 séries de 10 contrações e, ao final de cada série de 10 contrações, serão realizadas cinco contrações rápidas. Cada série será realizada em uma posição: deitado em decúbito lateral; sentado; de quatro apoios e em pé. | Other | Pelvic Floor Muscle Training |
| Pilates exercisesThe Pilates group will perform 10 solo exercises, containing stretching and strengthening for the main muscle groups, with a single series of 10 repetitions. | Other | Pilates exercises (PE) |
Primary outcome
Voiding diary
Time frame: 12 weeks
Identifies the frequency of urinary leakage. The participant will record, over the course of 7 days, at home, the number of episodes of urinary leakage during some effort, such as coughing, sneezing or jumping. If there are more than 3 urinary losses within a 7-day interval, the test is positive for UI.
International Consultation of Urinary questionnaire Incontinence Short Form (ICIQ-UI-SF)
Time frame: 12 weeks
Specific quality of life questionnaire for each aspect related to UI. It consists of four questions; the sum of the first three questions gives the score, and the fourth describes the type of UI. The maximum total score is 21, and the higher the score, the worse the UI severity and disorder.
PERFECT test
Time frame: 12 weeks
As a complement to the manometric evaluation, bidigital palpation will be performed. The PFM strength and resistance level will be classified using the modified Oxford scale, where 0 is the absence of muscle strength and 5 means a strong contraction with movement correct "squeeze" and "suction". Participants will attempt maximum contractions in terms of strength and endurance three times, with 30-second rest intervals between contractions. The closer to a score of 5, the better the MAP.
FSFI Questionnaire (Female Sexual Function Index)
Time frame: 12 weeks
To assess women's sexual function, the domains: desire, arousal, lubrication, orgasm, satisfaction and pain are used. It has 19 items. Each question presents a possibility of response with a pattern from 0 to 5, where at the end you can have the result of the scores of each domain and also of the total score, where values below or equal to 26.55 indicate sexual dysfunction.
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 30 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Laís Campos de Oliveira, PhD principal investigator
Universidade Estadual do Norte do Paraná
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PFMT and Pilates exercises in people with Urinary Incontinence , Stress, run by Universidade Estadual do Norte do Parana 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 30 Sep 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?
Voiding diary (time frame: 12 weeks). The study lists 4 primary outcomes in all. 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 30 Sep 2026.