Laser TherapyPBMT-IUENCT05096936
Pilates Method and/or Photobiomodulation in Women With Stress Urinary Incontinence
A study testing Pilates and Photobiomodulation in people with Laser Therapy and Urinary Incontinence,Stress, run by Universidade de Caxias do Sul at 1 site in Brazil.
Trial summary
The present study is a clinical intervention applied to patients with urinary incontinence, with the intention of verifying the effects of the Pilates method associated or not with photobiomodulation with static magnetic field. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Laser Therapy, Urinary Incontinence,Stress, Pilates Method
- What is being tested?
- Pilates and Photobiomodulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteBrazil
- Study dates
- 14 Oct 2021to 19 Jan 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 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women between 30 and 60 years old;
- Present a clinical diagnosis of SUI;
- The patient must be available at pre-scheduled times for a period of 12 weeks, with full participation;
- The participant must agree with the methodology proposed by the project and, if so, must sign the TCLE as legal proof of their participation.
Who cannot join
- Patients with urge urinary incontinence;
- Constant flow urinary incontinence and stress urinary incontinence during the gestational period (because these are possible transitory cases due to pregnancy);
- Women who have difficulty in understanding;
- Patients who have more than one absence per month during the interventions.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clínica Escola da Faculdade Cenecista de Bento Gonçalves Clínica Escola CNECBG
Bento Gonçalves, Rio Grande do Sul, 95.700-000
About this study
Official title: Pilates Method and/or Photobiomodulation Therapy Combined to Static Magnetic Field in Women With Stress Urinary Incontinence: What is Better?
The present study is a clinical intervention applied to patients with urinary incontinence, with the intention of verifying the effects of the Pilates method associated or not with photobiomodulation with static magnetic field. The sample will consist of women with stress urinary incontinence from Bento Gonçalves attended at the school clinic of Faculdade Cenecista de Bento Gonçalves.
- Conditions
- Laser Therapy, Urinary Incontinence,Stress, Pilates Method
- Being tested
- Pilates, Photobiomodulation
- 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.
PilatesOther
Also called Pilates exercise, Pilates Methods
The solo Pilates method will be applied twice a week for 12 weeks using the following exercises:
20 Breaths, Double leg stretch, Single leg stretch, Leg circles, Hip lift on ball, Abdominal tightening on ball, Alternating two supports, Side bend, Side kick - side kick, Side kicks, Shell and Swan and Neck pull stretches; in the tenth session, we evolved some exercises: The saw, Swan dive, Book close series, Hip lift on the ball and Front pulls; in the eighteenth session we changed again some exercises for: Leg pull back, Rolling like a Ball, Swimming, Roll over and Leg pull front.
PhotobiomodulationOther
Applications of FBM or placebo (MR4 ACTIVet PRO Laser Shower Portable, MRM, USA) will last for 115s and will deliver 60 J at each point. The mode of application, with the patient supine on a stretcher, with the grouping probe held stationary in contact with the skin, at a 90-degree angle, in the pubic mound and in the perineum region.
| Study group | Role | What they receive |
|---|---|---|
| Pilates PBMT | Experimental | This group will receive training in the Pilates method associated with the effective application of photobiomodulation. Receives: Other: Pilates; Other: Photobiomodulation |
| Pilates | Experimental | This group will receive training in the Pilates method associated with the not effective (placebo) application of photobiomodulation. Receives: Other: Pilates |
| PBMT | Placebo comparator | This group will receive effective application of photobiomodulation and will not perform the pilates method training Receives: Other: Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
decreased urinary loss
PAD test
Measured: 01, 09, 17 and 24 day of intervention.
Secondary outcomes (2)
single-digital vaginal touch
Muscle strength will be assessed through the unidigital vaginal touch, applied by a "blind" evaluator, so called because she does not monitor the performance of the interventions, as well as their respective evolutions during treatment, this assessment is subjective and will be classified by the scale of Modified Oxford (scale with a score between 0-5; 0- absence of muscle response, 1- Outline of non-sustained contraction; 2- presence of small intensity contraction, but which is sustained; 3- moderate contraction, felt as an increase in intravaginal pressure, which compresses the examiner's fingers with a small cranial elevation of the vaginal wall; 4- satisfactory contraction, which squeezes the examiner's fingers with elevation of the vaginal wall towards the pubic symphysis; 5- strong contraction, firm compression of the fingers of the examiner with positive movement towards the pubic symphysis).
Measured: 01 and 24 day of intervention.
International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
The ICIQ-SF is a questionnaire used to assess urinary incontinence, consisting of six questions that assess the frequency, severity of urinary loss and the impact of urinary incontinence on daily life, in addition to a sequence of eight self-diagnostic items, related to causes or incontinence situations that are not scored. The sum of the scores for questions three, four and five ranges from 0 to 21, and the higher the total score, the greater the severity of urinary incontinence. The impact of daily life is defined according to the score of question five; (0) not at all, (1-3) mild, (4-6) moderate, (7-9) severe, and (10) very severe.
Measured: 01 and 24 day of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start14 Oct 2021
- Primary completion30 Dec 2021
- Study completion19 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Laser TherapyStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade de Caxias do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thiago De Marchi, DR, Universidade de Caxias do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096936
- Sponsor's protocol ID
- PBMT and IUE
- Acronym
- PBMT-IUE
- Status last verified
- May 2023
- First submitted
- 14 Oct 2021
- Last updated
- 11 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Knorst MR, Resende TL, Santos TG, Goldim JR. The effect of outpatient physical therapy intervention on pelvic floor muscles in women with urinary incontinence. Braz J Phys Ther. 2013 Sep-Oct;17(5):442-9. doi: 10.1590/S1413-35552012005000117. Epub 2013 Oct 21. English, Portuguese.
PubMed 24173346De Marchi T, Leal Junior EC, Bortoli C, Tomazoni SS, Lopes-Martins RA, Salvador M. Low-level laser therapy (LLLT) in human progressive-intensity running: effects on exercise performance, skeletal muscle status, and oxidative stress. Lasers Med Sci. 2012 Jan;27(1):231-6. doi: 10.1007/s10103-011-0955-5. Epub 2011 Jul 8.
PubMed 21739259Coyne KS, Zhou Z, Thompson C, Versi E. The impact on health-related quality of life of stress, urge and mixed urinary incontinence. BJU Int. 2003 Nov;92(7):731-5. doi: 10.1046/j.1464-410x.2003.04463.x.
PubMed 14616456de Almeida P, Lopes-Martins RA, De Marchi T, Tomazoni SS, Albertini R, Correa JC, Rossi RP, Machado GP, da Silva DP, Bjordal JM, Leal Junior EC. Red (660 nm) and infrared (830 nm) low-level laser therapy in skeletal muscle fatigue in humans: what is better? Lasers Med Sci. 2012 Mar;27(2):453-8. doi: 10.1007/s10103-011-0957-3. Epub 2011 Jul 22.
PubMed 21814736
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilates Method and/or Photobiomodulation Therapy Combined to Static Magnetic Field in Women With Stress Urinary Incontinence: What is Better?
- ClinicalTrials.gov ID
- NCT05096936
- Acronym / sponsor ID
- PBMT-IUE / PBMT and IUE
- Conditions
- Laser Therapy, Urinary Incontinence,Stress, Pilates Method
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Universidade de Caxias do SulUniversity, hospital or other
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 19 Jan 2023 (actual)
- First posted
- 27 Oct 2021 (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.
The present study is a clinical intervention applied to patients with urinary incontinence, with the intention of verifying the effects of the Pilates method associated or not with photobiomodulation with static magnetic field. The sample will consist of women with stress urinary incontinence from Bento Gonçalves attended at the school clinic of Faculdade Cenecista de Bento Gonçalves.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pilates PBMT | Experimental | Other: Pilates, Other: PhotobiomodulationThis group will receive training in the Pilates method associated with the effective application of photobiomodulation. |
| Pilates | Experimental | Other: PilatesThis group will receive training in the Pilates method associated with the not effective (placebo) application of photobiomodulation. |
| PBMT | Placebo comparator | Other: PhotobiomodulationThis group will receive effective application of photobiomodulation and will not perform the pilates method training |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women between 30 and 60 years old;
- Present a clinical diagnosis of SUI;
- The patient must be available at pre-scheduled times for a period of 12 weeks, with full participation;
- The participant must agree with the methodology proposed by the project and, if so, must sign the TCLE as legal proof of their participation.
Key exclusion criteria (4 listed)
- Patients with urge urinary incontinence;
- Constant flow urinary incontinence and stress urinary incontinence during the gestational period (because these are possible transitory cases due to pregnancy);
- Women who have difficulty in understanding;
- Patients who have more than one absence per month during the interventions.
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 |
|---|---|---|
| PilatesAlso: Pilates exercise, Pilates MethodsThe solo Pilates method will be applied twice a week for 12 weeks using the following exercises: 20 Breaths, Double leg stretch, Single leg stretch, Leg circles, Hip lift on ball, Abdominal tightening on ball, Alternating two supports, Side bend, Side kick - side kick, Side kicks, Shell and Swan and Neck pull stretches; in the tenth session, we evolved some exercises: The saw, Swan dive, Book close series, Hip lift on the ball and Front pulls; in the eighteenth session we changed again some exercises for: Leg pull back, Rolling like a Ball, Swimming, Roll over and Leg pull front. | Other | Pilates, Pilates PBMT |
| PhotobiomodulationApplications of FBM or placebo (MR4 ACTIVet PRO Laser Shower Portable, MRM, USA) will last for 115s and will deliver 60 J at each point. The mode of application, with the patient supine on a stretcher, with the grouping probe held stationary in contact with the skin, at a 90-degree angle, in the pubic mound and in the perineum region. | Other | PBMT, Pilates PBMT |
Primary outcome
decreased urinary loss
Time frame: 01, 09, 17 and 24 day of intervention.
PAD test
2 secondary outcomes
single-digital vaginal touch
Time frame: 01 and 24 day of intervention.
International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
Time frame: 01 and 24 day of intervention.
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 11 May 2023.
- Background: PubMed 24173346Knorst MR, Resende TL, Santos TG, Goldim JR. The effect of outpatient physical therapy intervention on pelvic floor muscles in women with urinary incontinence. Braz J Phys Ther. 2013 Sep-Oct;17(5):442-9. doi: 10.1590/S1413-35552012005000117. Epub 2013 Oct 21. English, Portuguese.
- Background: PubMed 21739259De Marchi T, Leal Junior EC, Bortoli C, Tomazoni SS, Lopes-Martins RA, Salvador M. Low-level laser therapy (LLLT) in human progressive-intensity running: effects on exercise performance, skeletal muscle status, and oxidative stress. Lasers Med Sci. 2012 Jan;27(1):231-6. doi: 10.1007/s10103-011-0955-5. Epub 2011 Jul 8.
- Background: PubMed 14616456Coyne KS, Zhou Z, Thompson C, Versi E. The impact on health-related quality of life of stress, urge and mixed urinary incontinence. BJU Int. 2003 Nov;92(7):731-5. doi: 10.1046/j.1464-410x.2003.04463.x.
- Background: PubMed 21814736de Almeida P, Lopes-Martins RA, De Marchi T, Tomazoni SS, Albertini R, Correa JC, Rossi RP, Machado GP, da Silva DP, Bjordal JM, Leal Junior EC. Red (660 nm) and infrared (830 nm) low-level laser therapy in skeletal muscle fatigue in humans: what is better? Lasers Med Sci. 2012 Mar;27(2):453-8. doi: 10.1007/s10103-011-0957-3. Epub 2011 Jul 22.
- 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.
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 Pilates and Photobiomodulation in people with Laser Therapy and Urinary Incontinence,Stress, run by Universidade de Caxias do Sul 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 4 inclusion and 4 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 11 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. Some participants in this study may receive a placebo. 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?
decreased urinary loss (time frame: 01, 09, 17 and 24 day of intervention.). 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 NCT05096936, which also lists 4 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 11 May 2023.