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

Not Applicable

Completed

• Conditions: Laser Therapy; Urinary Incontinence,Stress; Pilates Method
• Interventions: Other: Pilates; Other: Photobiomodulation

• Registration Number: NCT05096936
• Lead Sponsor: Universidade de Caxias do Sul

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-14
• Study First Submitted: 2021-10-14
• Study First Submitted QC: 2021-10-14
• Study First Posted: 2021-10-27
• Primary Completion: 2021-12-30
• Study Completion: 2023-01-19
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pilates PBMT	Pilates	This group will receive training in the Pilates method associated with the effective application of photobiomodulation.
Pilates PBMT	Photobiomodulation	This group will receive training in the Pilates method associated with the effective application of photobiomodulation.
Pilates	Pilates	This group will receive training in the Pilates method associated with the not effective (placebo) application of photobiomodulation.
PBMT	Photobiomodulation	This group will receive effective application of photobiomodulation and will not perform the pilates method training

Primary Outcome Measures

Name	Time	Method
decreased urinary loss	01, 09, 17 and 24 day of intervention.	PAD test

Secondary Outcome Measures

Name	Time	Method
single-digital vaginal touch	01 and 24 day of intervention.	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)	01 and 24 day of intervention.	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.

Trial Locations

Locations (1)

Clínica Escola da Faculdade Cenecista de Bento Gonçalves Clínica Escola CNECBG; 🇧🇷 Bento Goncalves, RS, Brazil