Clinical trial NCT05096936: Pilates Method and/or Photobiomodulation in Women With Stress Urinary Incontinence
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
Overall status: COMPLETED
Phase: NA
Conditions: Laser Therapy
Urinary Incontinence,Stress
Pilates Method
Lead sponsor: Universidade de Caxias do Sul
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 33
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: decreased urinary loss
timeFrame: 01, 09, 17 and 24 day of intervention.
Secondary outcomes:
measure: single-digital vaginal touch
timeFrame: 01 and 24 day of intervention.
measure: International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
timeFrame: 01 and 24 day of intervention.
Other outcomes:
Locations:
city: Bento Goncalves
country: Brazil
facility: Clínica Escola da Faculdade Cenecista de Bento Gonçalves Clínica Escola CNECBG
state: RS
Study officials:
References:
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.
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.
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.
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.