Comparative study between Laser therapy versus Pelvic Muscle Training in women with Stress Urinary Incontinence
- Conditions
- nspecified Urinary IncontinenceM01.975
- Registration Number
- RBR-4ckch8
- Lead Sponsor
- Faculdade de Ciência Médicas da Universidade Estadual de Campinas
- Brief Summary
Pelvic floor muscle training (PFMT) is considered the first-option as a conservative treatment for female stress urinary incontinence (SUI). However, there is still debate whether energy-based devices are effective for treating SUI.We aimed to assess whether PFMT and fractional CO2-laser may improve symptoms in SUI women. A parallel, randomized, non-blinded, non-inferiority trial included 94 of 144 women over 18 years of age with SUI into two groups. The CO2-laser group (n=47) received three vaginal applications at monthly intervals. The PFMT group (n=47) underwent two weekly sessions. Primary outcome was the mean-difference of International Continence Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) total-scores between groups after 3 and 6 months. Main secondary outcomes were questionnaires for assessment of pelvic floor symptoms (PFIQ-7), sexual function (FSFI), and improvement after treatment (PGI-I). A reduction in the ICIQ-SF total-score, PFIQ total-score and the UIQ score was perceived between baseline and 3-6 months in both groups. CO2-laser did not reach the non-inferiority margin when compared to PFMT in both follow-up periods and analyses. PGI-I assessment has shown an improvement in both groups.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Data analysis completed
- Sex
- Female
- Target Recruitment
- Not specified
Women with 18 years old or over; with sintoms of Stress Urinary Incontinence - SUI; with positive effort test or valsalva manouver and/or urodynamics findings of Stress Urinary Incontinence - SUI and residual volume less than 100 ml or 20 % of voided volume superior 300ml; in case of women with a negative stress test with anamnesis suggesting Stress Urinary Incontinence , women with a positive urodynamic study for Stress Urinary Incontinence will be included
Women with overactive bladder; or urodynamic finding of detrusor overactivity; women with repetitive Urinary Tract Infection; woman with previous urogynecology surgeries; with previous treatment of radioterapy or Pelvic Organ Prolapse (POP) more than 2 years; women with previous and recently history of bladder stone; urinary fistula or divertíiculum
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome was the mean difference of ICIQ-SF(International Consultation on Incontinence Questionnaire - Short Form ) which allows us to qualify and quantify the urinary loss and to investigate its impact on the quality of life between laser and PFMT groups after 3 and 6 months.Improvement of stress urinary incontinence is expected through 3 sessions of vaginal laser theraphy application over a 12 week treatment period<br>
- Secondary Outcome Measures
Name Time Method Clinically evaluate through questionaires the main secondary outcomes were pelvic floor symptoms measured by the Pelvic Floor Impact Questionnaire (PFIQ) – 7;Evaluate the clinical conditions of women related to sexual activity, as well as female sexual function, through the validated Female Sexual Function Index (FSFI) questionnaire;Evaluate subjective post-intervention improvement using the Patient Global Impression of Improvement (PGI-I) questionnaire