Urinary Incontinence StressNCT02664714
Individual Pelvic Floor Muscle Training Versus Individual With Group Versus Group for Stress Urinary Incontinence
A study testing PFMT in people with Urinary Incontinence Stress, run by Universidade Federal de Sao Carlos.
Trial summary
The aim of this study is to evaluate if the training of pelvic floor muscles, which associates an individualized treatment progressing to a group treatment, would be more effective than an individualized training only or groups only. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence Stress
- What is being tested?
- PFMT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2017
- 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 from the age of 18 years old who present urinary incontinence stress
Who cannot join
- urge urinary incontinence (UUI) in an isolated form, neuromuscular diseases, other diseases (asthma, tumors, heart failure, absence of pelvic floor muscle contraction (grade 0) verified by modified Oxford scale, urinary infection, difficulty in understanding the study procedures, uncontrolled hypertension, presence of severe prolapse (visible prolapse in the vaginal opening), women with UI who have done physical therapy in the last 12 months, pregnancy,puerperium.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effects of Individual Pelvic Floor Muscle Training Versus Individual Treatment With Progression to Group Versus Group Training for Women With Stress Urinary Incontinence: Protocol for a Randomized Controlled Trial
The aim of this study is to evaluate if the training of pelvic floor muscles, which associates an individualized treatment progressing to a group treatment, would be more effective than an individualized training only or groups only.
Methods: Randomized controlled study which will be done from January to December of 2016, on Laboratory of Women's Health Research, Federal University of São Carlos-SP, Brazil.
Read more
Inclusion criteria: women with stress UI, older than 18 years old. The sample size calculation was performed using the GPower Software (3.1.5, Germany) and it was estimated a sample of 30 women in each group. The volunteers will be assessed before the intervention by a urinary symptoms evaluation form, King's Health Questionnaire, miccional diary, PERFECT scheme and perineometry.
After the evaluation will be performed the randomization of the volunteers by a blinded investigator and the volunteers will be allocated into three groups:
Group 1: Individualized Training Group 2: Individualized training with progression to group training Group 3: Group training only
For all groups it will be used the same protocol that was prepared according to the recommendations of the American College of Sports Medicine. Later, volunteers will be reassessed after 12 treatments, three months and six months (from the discharge date). It will be added in the reassessment the Self-efficacy Scale for Pelvic Floor Exercises Practice.
Primary outcome: severity measures of the King's Health Questionnaire.
Secondary outcome: miccional diary, PERFECT scheme, perineometry and Self-efficacy scale for Pelvic Floor Exercises Practice. Data normality will be tested by the Shapiro-Wilk test (SPSS 19.0). The comparison between the evaluations will be performed by ANOVA, and the comparison between groups will be performed by Student t-test (independent measures). In order to measure the practical significance of the data, the effect size and the confidence interval (CI) will be calculated. A 5% significance level will be assumed. This study was approved by the Research Ethics Committee of the Federal University of São Carlos, São Carlos- SP, Brazil (Protocol 1207393).
Read the detailed description
This is a blinded randomized controlled clinical trial. Data collection will be performed at the Women's Health research laboratory (WHRL), allocated in the Department of Physical Therapy of Federal University of São Carlos, from January 2016 to December 2016.
The project was approved by the Research Ethics Committee (REC) of Federal University of São Carlos (UFSCar) (Number 1207393). Patients will receive information about the research and those who consent to participate, will sign the free informed consent form.
The sample size calculation was performed using the GPower Software (3.1.5, Germany) based on the study of Pereira et al (2011) considering the intergroup comparison of data post treatment of the severity measurement of the King's Health Questionnaire. It was considered the ANOVA (repeated measures), 80% power, effect size of 0.40 and 5% of significance level, being estimated a sample size of 30 subjects.
- Conditions
- Urinary Incontinence Stress
- Being tested
- PFMT
- Keywords
- physiotherapy, perineometer, adherence
- 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
Also called pelvic floor muscles training
Participating volunteers of all groups will receive guidance about the anatomy and function of the pelvic floor muscles (PFM) and how to perform a properly contraction: as strong as possible and eliminating at the most the contraction of the gluteus, abdominals and adductors. For all groups it will be used the same protocol which was developed for this study, with progression parameters of the PFMT based on the recommendations for the strength training of the American College of Sports Medicine (VICKI, 2001).
| Study group | Role | What they receive |
|---|---|---|
| PFMT Individualized | Active comparator | 12 Individualized pelvic floor muscle training:FAST CONTRACTIONS(repetitions) weeks 1(5x),2(10x),3(15x), 4(20x),5(30x),6(40x) 7-12(50x)SUSTAINED CONTRACTIONSNumber of series:weeks: 1 and 2(2), 3-6(3), 7-12(4)Repetitions:week 1(6) week 2(8), weeks 3-12 (10)Sustained contraction time/Resting time: weeks 1(2s/4s),2(3s/6s), 3(4s/8s) 4(5s/10s), 5(5s/5s), 6(5s/5s), 7(6s/6s),8(6s/6s), 9(8s/8s) 10(8s/8s), 11(10s/10s),12(10s/10s) Receives: Other: PFMT |
| PFMT individualized with group | Experimental | 12 Individualized pelvic floor muscle training:FAST CONTRACTIONS(repetitions) weeks 1(5x),2(10x),3(15x), 4(20x),5(30x),6(40x) 7-12(50x)SUSTAINED CONTRACTIONSNumber of series:weeks: 1 and 2(2), 3-6(3), 7-12(4)Repetitions:week 1(6) week 2(8), weeks 3-12 (10)Sustained contraction time/Resting time: weeks 1(2s/4s),2(3s/6s), 3(4s/8s) Receives: Other: PFMT |
| 12 group PFMT | Active comparator | 12 Individualized pelvic floor muscle training:FAST CONTRACTIONS(repetitions) weeks 1(5x),2(10x),3(15x), 4(20x),5(30x),6(40x) 7-12(50x)SUSTAINED CONTRACTIONSNumber of series:weeks: 1 and 2(2), 3-6(3), 7-12(4)Repetitions:week 1(6) week 2(8), weeks 3-12 (10)Sustained contraction time/Resting time: weeks 1(2s/4s),2(3s/6s), 3(4s/8s) Receives: Other: PFMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity measures of the King's Health Questionnaire
In the first assessment volunteers will answer the King's Health Questionnaire
Measured: 6 months
Secondary outcomes (1)
mictional diary, PERFECT scheme, perineometry and Self-efficacy scale for Pelvic Floor Exercises Practice
the volunteer will be placed in the supine position with flexed hip and knees. Initially, it will be observed the vaginal mucosa condition, the presence of atrophies, sensitivity, pelvic organ prolapse and the tone of the vaginal wall. Then, it will be performed the muscle function evaluation through the PERFECT scale which was developed, the researcher will introduce the index finger about 4 cm into the volunteer vaginal canal and will guide her to contract the PFM.After, it will be evaluated the pelvic floor muscles contraction pressure through the Peritron equipment (Cardio Design,Australia) and is equipped with a vaginal probe. The perineometer probe will be coated with a male non-lubricated condom and will be introduced with KY® lubricant gel into the volunteer's vagina.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vilena Figueiredo Xavier, Universidade Federal de Sao Carlos
- Investigators
- Vilena F Xavier, Principal investigator, Programa de Pós-Graduação em Fisioterapia - UFSCar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664714
- Sponsor's protocol ID
- 5015537
- Status last verified
- Jan 2016
- First submitted
- 16 Dec 2015
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
BØ K, LARSEN S, OSEID S, et al. Knowledge about and ability to correct pelvic floor muscle exercises in women with urinary stress incontinence. Neurourol Urodyn. 1988;7:261-262. BØ K, TALSETH T, VINSNES A: Randomized controlled trial on the effect of pelvic floor muscle training on the quality of life and sexual problems in genuine stress incontinent women. Acta Obstet Gynecol Scand, 79:598-603, 2000. BO K, SHERBURN M. Evaluation of female pelvic-floor muscle function and strength. Phys Ther; 85 (3): 269 -82, 2005. BØ, K. AND HILDE, G. Does it work in the long term?-A systematic review on pelvic floor muscle training for female stress urinary incontinence. Neurourol. Urodyn., 32: 215-223, 2013. BORELLO-FRANCE DF, ZYCZYNSKI HM, DOWNEY PA, RAUSE CR, WISLER JA. Effect of pelvic floor muscles exercise position on continence and quality of life outcomes in women with stress urinary incontinence.Phys Ther. 86:974-86, 2006.
Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.
PubMed 39704322
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Individual Pelvic Floor Muscle Training Versus Individual Treatment With Progression to Group Versus Group Training for Women With Stress Urinary Incontinence: Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02664714
- Acronym / sponsor ID
- 5015537
- Conditions
- Urinary Incontinence Stress
- Keywords
- physiotherapy, perineometer, adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 27 Jan 2016 (estimated)
- 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.
The aim of this study is to evaluate if the training of pelvic floor muscles, which associates an individualized treatment progressing to a group treatment, would be more effective than an individualized training only or groups only.
Methods: Randomized controlled study which will be done from January to December of 2016, on Laboratory of Women's Health Research, Federal University of São Carlos-SP, Brazil.
Inclusion criteria: women with stress UI, older than 18 years old. The sample size calculation was performed using the GPower Software (3.1.5, Germany) and it was estimated a sample of 30 women in each group. The volunteers will be assessed before the intervention by a urinary symptoms evaluation form, King's Health Questionnaire, miccional diary, PERFECT scheme and perineometry.
After the evaluation will be performed the randomization of the volunteers by a blinded investigator and the volunteers will be allocated into three groups:
Group 1: Individualized Training Group 2: Individualized training with progression to group training Group 3: Group training only
For all groups it will be used the same protocol that was prepared according to the recommendations of the American College of Sports Medicine. Later, volunteers will be reassessed after 12 treatments, three months and six months (from the discharge date). It will be added in the reassessment the Self-efficacy Scale for Pelvic Floor Exercises Practice.
Primary outcome: severity measures of the King's Health Questionnaire.
Secondary outcome: miccional diary, PERFECT scheme, perineometry and Self-efficacy scale for Pelvic Floor Exercises Practice. Data normality will be tested by the Shapiro-Wilk test (SPSS 19.0). The comparison between the evaluations will be performed by ANOVA, and the comparison between groups will be performed by Student t-test (independent measures). In order to measure the practical significance of the data, the effect size and the confidence interval (CI) will be calculated. A 5% significance level will be assumed. This study was approved by the Research Ethics Committee of the Federal University of São Carlos, São Carlos- SP, Brazil (Protocol 1207393).
Detailed description
This is a blinded randomized controlled clinical trial. Data collection will be performed at the Women's Health research laboratory (WHRL), allocated in the Department of Physical Therapy of Federal University of São Carlos, from January 2016 to December 2016.
The project was approved by the Research Ethics Committee (REC) of Federal University of São Carlos (UFSCar) (Number 1207393). Patients will receive information about the research and those who consent to participate, will sign the free informed consent form.
The sample size calculation was performed using the GPower Software (3.1.5, Germany) based on the study of Pereira et al (2011) considering the intergroup comparison of data post treatment of the severity measurement of the King's Health Questionnaire. It was considered the ANOVA (repeated measures), 80% power, effect size of 0.40 and 5% of significance level, being estimated a sample size of 30 subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PFMT Individualized | Active comparator | Other: PFMT12 Individualized pelvic floor muscle training:FAST CONTRACTIONS(repetitions) weeks 1(5x),2(10x),3(15x), 4(20x),5(30x),6(40x) 7-12(50x)SUSTAINED CONTRACTIONSNumber of series:weeks: 1 and 2(2), 3-6(3), 7-12(4)Repetitions:week 1(6) week 2(8), weeks 3-12 (10)Sustained contraction time/Resting time: weeks 1(2s/4s),2(3s/6s), 3(4s/8s) 4(5s/10s), 5(5s/5s), 6(5s/5s), 7(6s/6s),8(6s/6s), 9(8s/8s) 10(8s/8s), 11(10s/10s),12(10s/10s) |
| PFMT individualized with group | Experimental | Other: PFMT12 Individualized pelvic floor muscle training:FAST CONTRACTIONS(repetitions) weeks 1(5x),2(10x),3(15x), 4(20x),5(30x),6(40x) 7-12(50x)SUSTAINED CONTRACTIONSNumber of series:weeks: 1 and 2(2), 3-6(3), 7-12(4)Repetitions:week 1(6) week 2(8), weeks 3-12 (10)Sustained contraction time/Resting time: weeks 1(2s/4s),2(3s/6s), 3(4s/8s) |
| 12 group PFMT | Active comparator | Other: PFMT12 Individualized pelvic floor muscle training:FAST CONTRACTIONS(repetitions) weeks 1(5x),2(10x),3(15x), 4(20x),5(30x),6(40x) 7-12(50x)SUSTAINED CONTRACTIONSNumber of series:weeks: 1 and 2(2), 3-6(3), 7-12(4)Repetitions:week 1(6) week 2(8), weeks 3-12 (10)Sustained contraction time/Resting time: weeks 1(2s/4s),2(3s/6s), 3(4s/8s) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women from the age of 18 years old who present urinary incontinence stress
Key exclusion criteria (1 listed)
- urge urinary incontinence (UUI) in an isolated form, neuromuscular diseases, other diseases (asthma, tumors, heart failure, absence of pelvic floor muscle contraction (grade 0) verified by modified Oxford scale, urinary infection, difficulty in understanding the study procedures, uncontrolled hypertension, presence of severe prolapse (visible prolapse in the vaginal opening), women with UI who have done physical therapy in the last 12 months, pregnancy,puerperium.
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 |
|---|---|---|
| PFMTAlso: pelvic floor muscles trainingParticipating volunteers of all groups will receive guidance about the anatomy and function of the pelvic floor muscles (PFM) and how to perform a properly contraction: as strong as possible and eliminating at the most the contraction of the gluteus, abdominals and adductors. For all groups it will be used the same protocol which was developed for this study, with progression parameters of the PFMT based on the recommendations for the strength training of the American College of Sports Medicine (VICKI, 2001). | Other | 12 group PFMT, PFMT Individualized, PFMT individualized with group |
Primary outcome
severity measures of the King's Health Questionnaire
Time frame: 6 months
In the first assessment volunteers will answer the King's Health Questionnaire
1 secondary outcome
mictional diary, PERFECT scheme, perineometry and Self-efficacy scale for Pelvic Floor Exercises Practice
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
- BackgroundBØ K, LARSEN S, OSEID S, et al. Knowledge about and ability to correct pelvic floor muscle exercises in women with urinary stress incontinence. Neurourol Urodyn. 1988;7:261-262. BØ K, TALSETH T, VINSNES A: Randomized controlled trial on the effect of pelvic floor muscle training on the quality of life and sexual problems in genuine stress incontinent women. Acta Obstet Gynecol Scand, 79:598-603, 2000. BO K, SHERBURN M. Evaluation of female pelvic-floor muscle function and strength. Phys Ther; 85 (3): 269 -82, 2005. BØ, K. AND HILDE, G. Does it work in the long term?-A systematic review on pelvic floor muscle training for female stress urinary incontinence. Neurourol. Urodyn., 32: 215-223, 2013. BORELLO-FRANCE DF, ZYCZYNSKI HM, DOWNEY PA, RAUSE CR, WISLER JA. Effect of pelvic floor muscles exercise position on continence and quality of life outcomes in women with stress urinary incontinence.Phys Ther. 86:974-86, 2006.
- Derived from this study: PubMed 39704322Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.
- test linkLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Vilena F Xavier principal investigator
Programa de Pós-Graduação em Fisioterapia - UFSCar
Questions about this trial
What is this clinical trial studying?
A study testing PFMT in people with Urinary Incontinence Stress, run by Universidade Federal de Sao Carlos.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vilena F Xavier (55-85996239673, vilenabf@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severity measures of the King's Health Questionnaire (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02664714, which also lists 2 linked publications.
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 27 Jan 2016; AzTrials last refreshed its copy on 7 Nov 2026.