Comparing two doses of botulinum toxin A in the tretatment of urinary symptoms
Not Applicable
- Conditions
- idiophatic overactive bladderC12.777.829.866
- Registration Number
- RBR-25k53m
- Lead Sponsor
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruitment completed
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
Female; adults; symptoms of overactive bladder; no response for conservative treatment or pharmacological contraindications.
Exclusion Criteria
Patients with any neurological condition; tumor; genital prolapse POPq III e IV; clinical or urodynamical evidence of bladder outflow obstruction.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome was change in clinical status, including urgency and urinary urgency incontinence episodes, daytime frequency and nocturia (voiding diary and ICIQ-OAB). We expected the treatment reduce these symptoms. Patients are assessed at weeks 4, 12 and 24 after injection. After 4 weeks, patients realize their improvements, with the peak at 12 weeks.
- Secondary Outcome Measures
Name Time Method Secondary efficacy outcomes were increase in maximum cystometric capacity (MCC)and volume at first desire to void (FDV). Urodynamics are performed at 12 and 24 weeks.;The impact of BoNT-A treatment on QoL was assessed by visual analogue scale (VAS, 0-10) where a higher score meant satisfaction with treatment. Also, patients should evaluate the response to therapy (PGI-I), recording how much better they were (very much better, much better, better, unchanged or worse).;Safety outcomes are urinary retention, urinary tract infection and required clean intermitent catheterization. We assessed at 4, 12 and 24 weeks through uroflowmetry and urodinamic. At 4 week, we have higher post void residual, increasing the need of catheterization. Urinary tract infection is assessed by culture urine in all visits. Patient who had symptomatic PVR (150mL or greater) required catheterization (CIC or indwelling).