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

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.

Study Overview

• Status: Completed
• Conditions: Laser Therapy; Urinary Incontinence,Stress; Pilates Method
• Intervention / Treatment: Other: Pilates; Other: Photobiomodulation

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Bento Goncalves, RS, Brazil, 95.700-000
      • Clínica Escola da Faculdade Cenecista de Bento Gonçalves Clínica Escola CNECBG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 56 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pilates PBMT; This group will receive training in the Pilates method associated with the effective application of photobiomodulation.	Other: Pilates; 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.; Other Names: Pilates exercise; Pilates Methods; Other: Photobiomodulation; 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.
Experimental: Pilates; This group will receive training in the Pilates method associated with the not effective (placebo) application of photobiomodulation.	Other: Pilates; 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.; Other Names: Pilates exercise; Pilates Methods
Placebo Comparator: PBMT; This group will receive effective application of photobiomodulation and will not perform the pilates method training	Other: Photobiomodulation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
decreased urinary loss	PAD test	01, 09, 17 and 24 day of intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	01 and 24 day of intervention.

Collaborators and Investigators

• Sponsor: Universidade de Caxias do Sul

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2021
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): January 19, 2023

Study Registration Dates

• First Submitted: October 14, 2021
• First Submitted That Met QC Criteria: October 14, 2021
• First Posted (Actual): October 27, 2021

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: PBMT and IUE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No