Other bladder disorders
Conditions
Interventions
This is a randomized clinical trial, with two arms, blinded to the study volunteers. The study will have a total of 140 patients, divided into two groups randomized through a computer program, in a 1:
Sponsors
Faculdade de Ciências Médicas da Universidade Estadual de Campinas
Faculdade de Ciências Médicas da Universidade Estadual de Campinas
Eligibility
Sex/Gender
Female
Age
45 Years to 65 Years
Inclusion criteria
Inclusion criteria: Women aged between 45 and 65 years; with symptoms of urinary incontinence with a predominance of symptoms of urgency or overactive bladder such as increased frequency, nocturia, urinary urgency, urge incontinence, enuresis; availability to attend the treatment on the date and places previously scheduled
Exclusion criteria
Exclusion criteria: Pacemaker use; presence of genital prolapse stages III and IV; decompensated heart disease; cognitive deficit / difficulty in understanding; peripheral or central neurological impairment (diabetic neuropathy, nerve damage, alzheimer, parkinson); presence of any type of cancer; presence of cervical dysplasia; presence of active urinary or vaginal infection; Decompensated diabetes; mixed incontinence with a predominance of loss on exertion; Patients using estrogen vaginally in the last 6 months; Patients in current use or in the last 6 months of oral hormone replacement therapy; Patient already submitted to prolapse or sling correction surgery; Patients with neurogenic bladder; Patients who underwent drug treatment for emergency incontinence or overactive bladder less than 6 months; Patients who underwent physiotherapeutic treatment of the pelvic floor muscles or transcutaneous electrical stimulation of the tibial nerve in the last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find significant improvement in mixed urinary incontinence with a predominance of urge or overactive bladder syndrome symptoms using fractional micro ablative radiofrequency associated with behavioral therapy when compared to the SHAM group associated with behavioral therapy. We will observe the results through the application of specific questionnaires such as the International Consultation on Incontinence Questionnaire - Short Form and Overactive Bladder | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to find improvement in urethral mobility and bladder neck, mucosal thickness and vaginal wall through ultrasound.;It is expected to find improvement in vaginal trophism only in the group with active fractional micro ablative radiofrequency evaluated through the International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS).;It is expected to find improvement in sexual function only in the group with active fractional micro ablative radiofrequency evaluated through the Female Sexual Function Index (FSFI) questionnaire.;It is expected to observe improvement in frequency, nocturia, voiding habits, and water intake in both groups, however, the group that will receive active micro ablative fractional radiofrequency will have better results evaluated by the voiding diary. | — |
Countries
Brazil
Contacts
Public ContactAnna Lygia Lunardi
Faculdade de Ciências Médicas da Universidade Estadual de Campinas
Outcome results
None listed