Overactive Urinary Bladder
Conditions
Interventions
This is a randomized, controlled, two-arm, parallel, blinded clinical trial. Women who meet the inclusion criteria and do not meet the exclusion criteria will be randomized into 2 groups. The randomiz
E02.831.535.468.800
Sponsors
Universidade Estadual de Campinas - UNICAMP
Universidade Estadual de Campinas - UNICAMP
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Brazil
Contacts
Public ContactLetícia Galhardo
Universidade Estadual de Campinas - UNICAMP
Outcome results
None listed