drugset / Trial / NCT05652036

Procedural Discomfort Related to Number of Intradetrusor Botox Injections

NCT05652036

Phase 4 Completed 108 enrolled The Methodist Hospital Research Institute
RandomizedParallel-groupSingle-blindTreatment

Summary

Injection of intradetrusor OnabotulinumtoxinA (BTX-A) is a highly efficacious therapy with a reliable safety profile and demonstrable improvements in subjective and objective measures for overactive bladder (OAB) symptom control. This procedure can be performed in the office with an evidence-based standard dosing of 100 units for idiopathic OAB. This is a single-blinded, randomized control trial is to evaluate and optimize the technique for performing intradetrusor injections of BTX-A for idiopathic OAB. This trial proposes two different reconstitution and injection schema to study patient-centered outcomes related to procedural discomfort and symptom relief.

Timeline

Start
2022-07-07
Primary completion
2023-04-06
Completion
2023-05-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Botulinum toxin type A Protein / enzyme biologic 100 iu

Indications