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Pilates Method and/or Photobiomodulation in Women With Stress Urinary Incontinence (PBMT-IUE)

Primary Purpose

Laser Therapy, Urinary Incontinence,Stress, Pilates Method

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Pilates
Photobiomodulation
Sponsored by
Universidade de Caxias do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laser Therapy

Eligibility Criteria

30 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Clínica Escola da Faculdade Cenecista de Bento Gonçalves Clínica Escola CNECBG

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Pilates PBMT

Pilates

PBMT

Arm Description

This group will receive training in the Pilates method associated with the effective application of photobiomodulation.

This group will receive training in the Pilates method associated with the not effective (placebo) application of photobiomodulation.

This group will receive effective application of photobiomodulation and will not perform the pilates method training

Outcomes

Primary Outcome Measures

decreased urinary loss
PAD test

Secondary Outcome Measures

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).
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.

Full Information

First Posted
October 14, 2021
Last Updated
May 9, 2023
Sponsor
Universidade de Caxias do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT05096936
Brief Title
Pilates Method and/or Photobiomodulation in Women With Stress Urinary Incontinence
Acronym
PBMT-IUE
Official Title
Pilates Method and/or Photobiomodulation Therapy Combined to Static Magnetic Field in Women With Stress Urinary Incontinence: What is Better?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 14, 2021 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
January 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade de Caxias do Sul

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. The sample will consist of women with stress urinary incontinence from Bento Gonçalves attended at the school clinic of Faculdade Cenecista de Bento Gonçalves.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laser Therapy, Urinary Incontinence,Stress, Pilates Method

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pilates PBMT
Arm Type
Experimental
Arm Description
This group will receive training in the Pilates method associated with the effective application of photobiomodulation.
Arm Title
Pilates
Arm Type
Experimental
Arm Description
This group will receive training in the Pilates method associated with the not effective (placebo) application of photobiomodulation.
Arm Title
PBMT
Arm Type
Placebo Comparator
Arm Description
This group will receive effective application of photobiomodulation and will not perform the pilates method training
Intervention Type
Other
Intervention Name(s)
Pilates
Other Intervention Name(s)
Pilates exercise, Pilates Methods
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Photobiomodulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
decreased urinary loss
Description
PAD test
Time Frame
01, 09, 17 and 24 day of intervention.
Secondary Outcome Measure Information:
Title
single-digital vaginal touch
Description
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).
Time Frame
01 and 24 day of intervention.
Title
International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
Description
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.
Time Frame
01 and 24 day of intervention.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Clínica Escola da Faculdade Cenecista de Bento Gonçalves Clínica Escola CNECBG
City
Bento Goncalves
State/Province
RS
ZIP/Postal Code
95.700-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24173346
Citation
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.
Results Reference
background
PubMed Identifier
21739259
Citation
De 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.
Results Reference
background
PubMed Identifier
14616456
Citation
Coyne 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.
Results Reference
background
PubMed Identifier
21814736
Citation
de 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.
Results Reference
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Pilates Method and/or Photobiomodulation in Women With Stress Urinary Incontinence

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