Pilates Method and/or Photobiomodulation in Women With Stress Urinary Incontinence

NCT05096936 | Completed

• 1 other identifier: PBMT and IUE
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Laser Therapy; Urinary Incontinence,Stress; Pilates Method

Outcome Measures

Primary Outcomes (1)

• decreased urinary loss

  PAD test

  01, 09, 17 and 24 day of intervention.

Secondary Outcomes (2)

• single-digital vaginal touch

  01 and 24 day of intervention.

• International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)

  01 and 24 day of intervention.

Study Arms (3)

Pilates PBMT

EXPERIMENTAL

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

Other: Pilates; Other: Photobiomodulation

Pilates

EXPERIMENTAL

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

Other: Pilates

PBMT

PLACEBO COMPARATOR

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

Other: Photobiomodulation

Interventions

Pilates OTHER

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.

Also known as: Pilates exercise, Pilates Methods

Pilates; Pilates PBMT

Photobiomodulation OTHER

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.

PBMT; Pilates PBMT

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade de Caxias do Sul: lead

Study Sites (1)

Clínica Escola da Faculdade Cenecista de Bento Gonçalves Clínica Escola CNECBG

Bento Gonçalves, Rio Grande do Sul, 95.700-000, Brazil

Location

Related Publications (4)

• 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.

  PMID: 24173346 BACKGROUND

• 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.

  PMID: 21739259 BACKGROUND

• 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.

  PMID: 14616456 BACKGROUND

• 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.

  PMID: 21814736 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Exercise Movement Techniques; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics; Laser Therapy; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: October 27, 2021
• Study Start: October 14, 2021
• Primary Completion: December 30, 2021
• Study Completion: January 19, 2023
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)