Urinary incontinence
Conditions
Interventions
Treatment consists of intramuscular application of botulinum toxin into the bladder wall, within the detrusor muscles. It is performed with direct visualization of the inside of the bladder, through c
only the investigator knows the administered dose. Given the transient effect of the medication, patients are allowed to request a new injection upon the recurrence of symptoms. Reapplication is possi
Sponsors
Irmandade da Santa Casa de Misericórdia de São Paulo
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Female partients; aged 18 years or older; diagnosis of idiopathic overactive bladder; refractoriness to treatment with behavioral measures and pharmacological therapy; or contraindication to the use of anticholinergics
Exclusion criteria
Exclusion criteria: Patients with cognitive deficit; extensive fibroids; tumors; grade III and IV prolapses; changes in bladder emptying, with high residue (above 150mL) or use of catheterization previously or repeat UTIs; predominant stress urinary incontinence; prior treatment with the toxin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is to detect a 35% difference in therapeutic success between groups at the 24th week. Therapeutic success is defined when the responses of patient global impression of improvement are very much better (1), much better and better (2) | — |
Secondary
| Measure | Time frame |
|---|---|
| As secondary outcomes, we expect clinical improvement quantified through the symptom questionnaire (International Consultation on Incontinence Questionnaire Overactive Bladder), reducing its value (can vary from 0 to 16). For urodynamic parameters, we expect increase in maximum cystometric capacity, non-detection of detrusor overactivity or, if detrusor overactivity is present, increase in the volume of the first detrusor overactivity. We also expected high treatment satisfaction, assessed using a visual analogue scale from 0 to 10;Safety outcomes are also secondary endpoints, assessed through the occurrence of urinary retention, urinary tract infection and the need for clean intermittent catheterization. An increase in post-void residual volume is observed after the intervention. The indication for catheterization is based on a PVR greater than 150 mL in symptomatic patients, or greater than 300 mL even in the absence of symptoms. UTIs episodes are more frequently observed following the intervention;Repeated injections are administered based on spontaneous demand. At the time of the second injection, patients have their initial doses changed: 300U-500U and 500U-300U dose. From the third injection onward, we use a standardized dose of 500U. As secondary outcomes, we assess the interval between first and second injections. Additionally, Additionally, we expect to observe maintenance of efficacy results in reapplications | — |
Countries
Brazil
Contacts
Public ContactDanielle;Luis Bezerra;de Toledo
Faculdade de Ciências Médicas da Santa Casa de São Paulo;Faculdade de Ciências Médicas da Santa Casa de São Paulo
Outcome results
None listed