Comparison of the application of Current Therapy to the unilateral versus bilateral tibial nerve in women with Urine Leakage
- Conditions
- Overactive Urinary BladderUrinary IncontinenceC12.050.351
- Registration Number
- RBR-6f2fgkn
- Lead Sponsor
- niversidade Estadual de Campinas - UNICAMP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Women aged 18 or over; diagnosed with overactive bladder syndrome or mixed urinary incontinence with predominance of urgency; women who voluntarily accept the informed consent form (ICF); know how to read and write
Neurological problems or suggestive of neurogenic bladder; proven or suspected pregnancy; any previous treatment for overactive bladder syndrome in the last 3 months; women diagnosed with interstitial cystitis; use of medication to treat overactive bladder syndrome (antimuscarinic and beta-adrenergic) in the last 3 months; women with a history of cervical, endometrial or vulvar cancer; previous pelvic radiotherapy or brachytherapy; women with signs and symptoms of Urinary Tract Infection (UTI) or Pelvic Inflammatory Disease at the time of enrollment; women with genital prolapses assessed at the surgical gynecology outpatient clinic and with a Pelvic Organ Prolapse Quantification (POP-Q) classification greater than grade 2; cardiac pacemaker; previous surgeries to treat urinary incontinence; decompensated diabetes mellitus; loss of peripheral sensitivity on physical examination; skin lesions where the electrode will be placed; use of metallic implants in the region of the lumbar spine, foot and ankle; hormone replacement therapy (HT) in the last 3 months
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Expected outcome 1: improvement in urinary symptoms in both groups, but greater in the bilateral group. Urinary symptoms will be assessed using questionnaires validated for Portuguese (QUID, ICIQ-SF and OAB), voiding diary carried out before and after the 12 intervention sessions and subjective report of the woman (question with LIKERT scale)
- Secondary Outcome Measures
Name Time Method Improvement in quality of life. We expect improvement in both groups, but greater in the bilateral group. Quality of life will be assessed using questionnaires validated for Portuguese (Incontinence Quality of life Questionnaire (I-QOL);Improvement in sexual função. We expect improvement in both groups, but greater in the bilateral group. Sexual function will be assessed using a questionnairevalidated for Portuguese (FSFI);Impact on sleep quality. We expect improvement in sleep quality in both groups, but higher in the bilateral group. Sleep quality will be assessed with a questionnaire validated for Portuguese (Patient-Reported Outcomes Measurement Information System (PROMIS);Impact on symptoms of anxiety and depression. We expect improvement in psychological symptoms in both groups, but greater in the bilateral group. Psychological symptoms will be evaluated with a questionnaire validated for Portuguese (DASS-21)