Urinary IncontinenceNCT05446792
Comparison Between Pelvic Muscle Training and Pilates Exercises for UI in Postmenopausal Women
A study testing PFMT and PE in people with Urinary Incontinence, run by Universidade Estadual do Norte do Parana at 1 site in Brazil.
Trial summary
Introduction: Urinary incontinence (UI) is a condition that affects around 40% of postmenopausal women and is therefore considered a public health problem. Conservative treatment is recommended, and pelvic floor muscle training (PMT) is considered the gold standard for this type of condition. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- PFMT and PE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2022to 14 Feb 2023
- 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
- Healthy volunteers accepted
- 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;
Show all 9Show fewer
- 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.
Brazil1 site
Universidade Estadual do Norte do Paraná
Jacarezinho, Paraná, 86400000
About this study
Official title: Comparison Between Pelvic Floor Muscle Training and Pilates Exercises on Urinary Incontinence in Postmenopausal Women: Randomized Controlled Trial
Introduction: Urinary incontinence (UI) is a condition that affects around 40% of postmenopausal women and is therefore considered a public health problem. Conservative treatment is recommended, and pelvic floor muscle training (PMT) is considered the gold standard for this type of condition. However, other possibilities of exercises have been studied to achieve continence, such as Pilates exercises, which focus on the stabilizing muscles and request a voluntary contraction of the muscles of the pelvic floor (PFM), it is believed that it can recruit fibers from these muscles, improving muscle function and episodes of urinary incontinence. However, the literature is still inconclusive regarding the effects of Pilates exercises on urinary incontinence and PFM function. Objective: To compare the effects of 3 months of muscle training, through TMAP and Pilates exercises on the improvement of UI in postmenopausal women. Methods: 40 postmenopausal women with urinary incontinence will be randomly assigned to two intervention groups: pelvic floor muscle training and Pilates exercises. The evaluations will be carried out before the interventions and after three months of them, and will involve the following instruments: urinary incontinence and aspects related to quality of life, assessed using the International Consultation of Urinary Incontinence questionnaire Short Form (ICIQ-UI-SF); 7-day voiding diary, used to identify possible modifiable factors related to urination and its frequency; Pad-test used to identify and quantify UI; Feeling Scale, to portray the affective valence of the exercises; Female Sexual Function Index, which will assess female sexual function; Manometric assessment of muscle strength and PFM endurance with Epi-no; and Manometric evaluation by bidigital palpation using the PERFECT test. Shapiro Wilk tests will be performed to verify normality, Student's t or Mann Whitney U test according to parametric or non-parametric distribution, ANCOVA for comparison between groups in the post-intervention, considering the 95% confidence interval (p<0.05) . The data will be processed in the SPSS 25.0 program.
Read the detailed description
The sample will be composed of 40 women in the post-menopausal period, that is, who are at least one year without menstruating, and who are aged between 50 and 70 years. The sample size calculation for this study was performed using the Bioestat 5.3 program (Mamirauá Institute, Amazonas, Brazil), taking into account the values of the ICIQ_SF instrument (name in English), made available in a previous study (SCHRADER et al., 2017). In this case, the post-intervention mean and standard deviation between the Pilates group (1.0 ± 1.15) and TMAP (3.42 ± 3.4) were used, with test power at 80% and alpha value at 0.05, which generated the need for 17 participants in each group. In order to meet eventual sample losses, 15% of participants will be added in each group, thus totaling 20 women in the Pilates group and 20 in the TMAP group.
The descriptive analysis of the data will be expressed in the form of mean, standard deviation and percentage delta of the difference. The verification of normality will occur by the Shapiro Wilk test. To verify if there are differences between the groups regarding the initial characteristics (age, weight, height and BMI), at the pre-intervention moment, the Student's t test will be used for independent samples or the Mann Whitney U test, in case the data show parametric or nonparametric distribution, respectively. For comparison between groups in the post-intervention ANCOVA will be used, with baseline data being used as covariates. If the data present a non-parametric characteristic, the comparison between the groups will be made using the Mann-Whitney U test, considering the difference between pre and post-intervention. The admitted confidence interval will be 95% (p<0.05). The data will be processed in the SPSS 25.0 program. 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 program GPower 3.1 (Franz Faul, Universitat Kiel, Germany) will be used.
- Conditions
- Urinary Incontinence
- Being tested
- PFMT, PE
- Keywords
- Post-menopause, Pilates, Muscle training of pelvic floor
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFMTOther
The PFMT will consist of 10 maximum voluntary contractions that must be maintained for at least 6 seconds. Participants will be encouraged to sustain the maximum contraction for a longer time each week. The interval time between contractions will be the same seconds as the contraction. Participants will perform 4 sets of 10 contractions, and at the end of each set of 10 contractions, five fast contractions will be performed. Each series will be performed in one position: lying in lateral decubitus; seated; on all fours and standing.
PEOther
The PE group will be instructed and reminded to voluntarily contract the PFMs during each repetition of the Pilates strengthening exercises. During the stretching exercises, the participant will be instructed not to perform the contraction.
The stretching and strengthening exercises will be performed in a single series of 10 repetitions, totaling 10 exercises aimed at the main muscle groups.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic floor muscle training (PFMT) | Active comparator | For the intervention of the PFMT group, which is non-invasive, 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 intervention of the PE group, in the first week the protocol will be used to familiarize the participants with the exercises, where the correct execution of the movements will be demonstrated and each principle of the method will be explained: concentration, centralization, precision, breathing, control and fluidity; and for familiarization with the correct voluntary contraction of the PFM. Participants in the PE group will be instructed and reminded to voluntarily contract the PFM during each repetition of the Pilates strengthening exercises. During the stretching exercises, the participant will be instructed not to perform the contraction. The springs will be changed according to the evolution of the participants, by replacing them with a spring of greater resistance. Basic equipment such as: Cadillac Trapezio, Combo Chair, Universal Reformer, Ladder Barrel and Wall Unit will be used. Receives: Other: PE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 3 months
Pad-test
Identifies and quantifies UI. The participant will be instructed to empty the bladder and ingest 500 ml of water, then place a previously weighed absorbent. The participant performs provocative maneuvers that will increase intra-abdominal pressure such as coughing, jumping and crouching, lasting approximately one hour. Soon after, the absorbent will be weighed again. If the absorbent weight is greater than 2 grams, the result was positive, identifying the UI. The greater the final weight of the pad, the greater the amount of urinary loss.
Measured: 3 months
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: 3 months
Manometric assessment of muscle strength and PFM endurance
The manometer probe will be inserted and inflated in the participant's vaginal canal, until the participant feels the probe contacting the vaginal wall. The participant will be guided to contract the MAP. When the musculature contracts, an increase in pressure is observed on the device's display. You will be asked for three maximum contractions with 30 second rest intervals between contractions. The values will be recorded in mmHg and the duration of the contraction will be recorded in seconds. The higher the score, the stronger the MAPs are.
Measured: 3 months
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: 3 months
Secondary outcomes (2)
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: 3 months
Feeling Scale - Pleasure and displeasure during exercise
The affective valence scale will be used to measure the participants' feelings of pleasure/affection in relation to the exercises. The score goes from +5 meaning pleasure during the exercise with a feeling of "very good"; down to -5, meaning displeasure, presenting the feeling of "very bad" during the execution of the exercise. The closer to +5, the more pleasure in performing the exercise.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start1 Jun 2022
- Primary completion7 Dec 2022
- Study completion14 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies 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 for twelve weeks, three times a week, for one hour, on non days consecutive. The Pilates exercises group will perform stretching and strengthening exercises in a single series of 10 repetitions, totaling 10 exercises aimed at the main muscle groups. The Pelvic floor muscle training group will consist of 10 maximal voluntary contractions that must be maintained for at least 6 seconds (participants will be encouraged to sustain the maximal contraction for a longer time each week). The interval time between contractions will be the same seconds as the contraction. Participants will perform 4 sets of 10 contractions, and at the end of each set of 10 contractions, five fast contractions will be performed. Each series will be performed in one position: 1st lying in lateral decubitus, 2nd sitting, 3rd on all fours and 4th standing.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 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 C Oliveira, PhD, Principal investigator, Universidade Estadual do Norte do ParanáRaphael G Oliveira, PhD, Study chair, Universidade Estadual do Norte do Paraná
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446792
- Sponsor's protocol ID
- TMAP X Pilates in the UI
- Status last verified
- May 2023
- First submitted
- 24 Jun 2022
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Andrade RL, Bo K, Antonio FI, Driusso P, Mateus-Vasconcelos ECL, Ramos S, Julio MP, Ferreira CHJ. An education program about pelvic floor muscles improved women's knowledge but not pelvic floor muscle function, urinary incontinence or sexual function: a randomised trial. J Physiother. 2018 Apr;64(2):91-96. doi: 10.1016/j.jphys.2018.02.010. Epub 2018 Mar 21.
PubMed 29574170Hay-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 39704322Gonzaga S, de Oliveira RG, Dutra LL, Oliveira LS, de Oliveira LC. Comparative analysis of pelvic floor muscle training and Pilates in managing urinary incontinence among postmenopausal women: a randomized controlled trial. Int Urogynecol J. 2024 Mar;35(3):561-569. doi: 10.1007/s00192-023-05712-0. Epub 2024 Jan 11.
PubMed 38206341
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Pelvic Floor Muscle Training and Pilates Exercises on Urinary Incontinence in Postmenopausal Women: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05446792
- Acronym / sponsor ID
- TMAP X Pilates in the UI
- Conditions
- Urinary Incontinence
- Keywords
- Post-menopause, Pilates, Muscle training of pelvic floor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidade Estadual do Norte do ParanaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 14 Feb 2023 (actual)
- First posted
- 7 Jul 2022 (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.
Introduction: Urinary incontinence (UI) is a condition that affects around 40% of postmenopausal women and is therefore considered a public health problem. Conservative treatment is recommended, and pelvic floor muscle training (PMT) is considered the gold standard for this type of condition. However, other possibilities of exercises have been studied to achieve continence, such as Pilates exercises, which focus on the stabilizing muscles and request a voluntary contraction of the muscles of the pelvic floor (PFM), it is believed that it can recruit fibers from these muscles, improving muscle function and episodes of urinary incontinence. However, the literature is still inconclusive regarding the effects of Pilates exercises on urinary incontinence and PFM function. Objective: To compare the effects of 3 months of muscle training, through TMAP and Pilates exercises on the improvement of UI in postmenopausal women. Methods: 40 postmenopausal women with urinary incontinence will be randomly assigned to two intervention groups: pelvic floor muscle training and Pilates exercises. The evaluations will be carried out before the interventions and after three months of them, and will involve the following instruments: urinary incontinence and aspects related to quality of life, assessed using the International Consultation of Urinary Incontinence questionnaire Short Form (ICIQ-UI-SF); 7-day voiding diary, used to identify possible modifiable factors related to urination and its frequency; Pad-test used to identify and quantify UI; Feeling Scale, to portray the affective valence of the exercises; Female Sexual Function Index, which will assess female sexual function; Manometric assessment of muscle strength and PFM endurance with Epi-no; and Manometric evaluation by bidigital palpation using the PERFECT test. Shapiro Wilk tests will be performed to verify normality, Student's t or Mann Whitney U test according to parametric or non-parametric distribution, ANCOVA for comparison between groups in the post-intervention, considering the 95% confidence interval (p<0.05) . The data will be processed in the SPSS 25.0 program.
Detailed description
The sample will be composed of 40 women in the post-menopausal period, that is, who are at least one year without menstruating, and who are aged between 50 and 70 years. The sample size calculation for this study was performed using the Bioestat 5.3 program (Mamirauá Institute, Amazonas, Brazil), taking into account the values of the ICIQ_SF instrument (name in English), made available in a previous study (SCHRADER et al., 2017). In this case, the post-intervention mean and standard deviation between the Pilates group (1.0 ± 1.15) and TMAP (3.42 ± 3.4) were used, with test power at 80% and alpha value at 0.05, which generated the need for 17 participants in each group. In order to meet eventual sample losses, 15% of participants will be added in each group, thus totaling 20 women in the Pilates group and 20 in the TMAP group.
The descriptive analysis of the data will be expressed in the form of mean, standard deviation and percentage delta of the difference. The verification of normality will occur by the Shapiro Wilk test. To verify if there are differences between the groups regarding the initial characteristics (age, weight, height and BMI), at the pre-intervention moment, the Student's t test will be used for independent samples or the Mann Whitney U test, in case the data show parametric or nonparametric distribution, respectively. For comparison between groups in the post-intervention ANCOVA will be used, with baseline data being used as covariates. If the data present a non-parametric characteristic, the comparison between the groups will be made using the Mann-Whitney U test, considering the difference between pre and post-intervention. The admitted confidence interval will be 95% (p<0.05). The data will be processed in the SPSS 25.0 program. 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 program GPower 3.1 (Franz Faul, Universitat Kiel, Germany) will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The interventions will last for twelve weeks, three times a week, for one hour, on non days consecutive. The Pilates exercises group will perform stretching and strengthening exercises in a single series of 10 repetitions, totaling 10 exercises aimed at the main muscle groups. The Pelvic floor muscle training group will consist of 10 maximal voluntary contractions that must be maintained for at least 6 seconds (participants will be encouraged to sustain the maximal contraction for a longer time each week). The interval time between contractions will be the same seconds as the contraction. Participants will perform 4 sets of 10 contractions, and at the end of each set of 10 contractions, five fast contractions will be performed. Each series will be performed in one position: 1st lying in lateral decubitus, 2nd sitting, 3rd on all fours and 4th standing.
| Arm | Type | Receives |
|---|---|---|
| Pelvic floor muscle training (PFMT) | Active comparator | Other: PFMTFor the intervention of the PFMT group, which is non-invasive, 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: PEFor the intervention of the PE group, in the first week the protocol will be used to familiarize the participants with the exercises, where the correct execution of the movements will be demonstrated and each principle of the method will be explained: concentration, centralization, precision, breathing, control and fluidity; and for familiarization with the correct voluntary contraction of the PFM. Participants in the PE group will be instructed and reminded to voluntarily contract the PFM during each repetition of the Pilates strengthening exercises. During the stretching exercises, the participant will be instructed not to perform the contraction. The springs will be changed according to the evolution of the participants, by replacing them with a spring of greater resistance. Basic equipment such as: Cadillac Trapezio, Combo Chair, Universal Reformer, Ladder Barrel and Wall Unit will be used. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- 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 (9 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);
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 |
|---|---|---|
| PFMTThe PFMT will consist of 10 maximum voluntary contractions that must be maintained for at least 6 seconds. Participants will be encouraged to sustain the maximum contraction for a longer time each week. The interval time between contractions will be the same seconds as the contraction. Participants will perform 4 sets of 10 contractions, and at the end of each set of 10 contractions, five fast contractions will be performed. Each series will be performed in one position: lying in lateral decubitus; seated; on all fours and standing. | Other | Pelvic floor muscle training (PFMT) |
| PEThe PE group will be instructed and reminded to voluntarily contract the PFMs during each repetition of the Pilates strengthening exercises. During the stretching exercises, the participant will be instructed not to perform the contraction. The stretching and strengthening exercises will be performed in a single series of 10 repetitions, totaling 10 exercises aimed at the main muscle groups. | Other | Pilates exercises (PE) |
Primary outcome
International Consultation of Urinary questionnaire Incontinence Short Form (ICIQ-UI-SF)
Time frame: 3 months
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.
Pad-test
Time frame: 3 months
Identifies and quantifies UI. The participant will be instructed to empty the bladder and ingest 500 ml of water, then place a previously weighed absorbent. The participant performs provocative maneuvers that will increase intra-abdominal pressure such as coughing, jumping and crouching, lasting approximately one hour. Soon after, the absorbent will be weighed again. If the absorbent weight is greater than 2 grams, the result was positive, identifying the UI. The greater the final weight of the pad, the greater the amount of urinary loss.
Voiding diary
Time frame: 3 months
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.
Manometric assessment of muscle strength and PFM endurance
Time frame: 3 months
The manometer probe will be inserted and inflated in the participant's vaginal canal, until the participant feels the probe contacting the vaginal wall. The participant will be guided to contract the MAP. When the musculature contracts, an increase in pressure is observed on the device's display. You will be asked for three maximum contractions with 30 second rest intervals between contractions. The values will be recorded in mmHg and the duration of the contraction will be recorded in seconds. The higher the score, the stronger the MAPs are.
PERFECT test
Time frame: 3 months
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.
2 secondary outcomes
FSFI Questionnaire (Female Sexual Function Index)
Time frame: 3 months
Feeling Scale - Pleasure and displeasure during exercise
Time frame: 3 months
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 9 May 2023.
- Background: PubMed 29574170de Andrade RL, Bo K, Antonio FI, Driusso P, Mateus-Vasconcelos ECL, Ramos S, Julio MP, Ferreira CHJ. An education program about pelvic floor muscles improved women's knowledge but not pelvic floor muscle function, urinary incontinence or sexual function: a randomised trial. J Physiother. 2018 Apr;64(2):91-96. doi: 10.1016/j.jphys.2018.02.010. Epub 2018 Mar 21.
- 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.
- Derived from this study: PubMed 38206341Gonzaga S, de Oliveira RG, Dutra LL, Oliveira LS, de Oliveira LC. Comparative analysis of pelvic floor muscle training and Pilates in managing urinary incontinence among postmenopausal women: a randomized controlled trial. Int Urogynecol J. 2024 Mar;35(3):561-569. doi: 10.1007/s00192-023-05712-0. Epub 2024 Jan 11.
- Individual participant dataSharing planned: No
Related trials for Urinary Incontinence
Not yet recruiting
Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
Chronic Low Back Pain, Urinary Incontinence
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy
Not yet recruiting
Feasibility of Resisted Expiratory Muscle Training for Females Assigned at Birth With Stress Urinary Incontinence: A Pilot Study
Stress Urinary Incontinence
RecruitingPhase 2
Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
Urinary Urge Incontinence, Stress Urinary Incontinence
RecruitingPhase 4
Prophylactic Antibiotics for Outpatient Urethral Bulking
Urinary Tract Infections, Stress Urinary Incontinence
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 C Oliveira, PhD principal investigator
Universidade Estadual do Norte do Paraná
Raphael G Oliveira, PhD study chair
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 PE in people with Urinary Incontinence, 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 9 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 9 May 2023. 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?
International Consultation of Urinary questionnaire Incontinence Short Form (ICIQ-UI-SF) (time frame: 3 months). The study lists 5 primary outcomes in all. 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 NCT05446792, which also lists 3 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 9 May 2023.