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Completed

NCT Number: NCT05096936

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

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.

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Key information

Conditions

Laser Therapy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Pilates Method Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urinary Incontinence,Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

30 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clínica Escola da Faculdade Cenecista de Bento Gonçalves Clínica Escola CNECBG

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Pilates exercise, Pilates Methods

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.

Primary outcomes

  1. decreased urinary loss

    Time frame: 01, 09, 17 and 24 day of intervention.

    PAD test

Secondary outcomes

  1. single-digital vaginal touch

    Time frame: 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).

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidade de Caxias do Sul

Other

Registry information

Official study title

Pilates Method and/or Photobiomodulation Therapy Combined to Static Magnetic Field in Women With Stress Urinary Incontinence: What is Better?

Acronym: PBMT-IUE

Important dates

Study start
2021
Primary completion
2021
Study completion
2023
First posted
Oct 27, 2021
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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