NCT05652036

Procedural Discomfort Related to Number of Intradetrusor Botox Injections

Procedural Discomfort Related to Number of Intradetrusor Injections of OnabotulinumtoxinA for Idiopathic Overactive Bladder: A Randomized Control Trial of an Alternate Reconstitution Volume and Injection Template Protocol

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This will be a single-blinded, parallel randomized control trial (RCT) utilizing two study arms. This trial will be designed and reported as outlined in the CONSORT guidelines The primary aim of this study is to evaluate perceived discomfort using the Numeric Pain Scale (NPS) during office injection of intradetrusor BTX-A via two different injection techniques and reconstitution volumes. The secondary aims of this study are to evaluate treatment effectiveness and patient satisfaction of treatment with BTX-A using validated questionnaires. Investigators will also compare procedure time and post-procedure complication rates between the two study groups. Study Groups: The patients will be randomized in a 1:1 fashion to one of two groups: * 100 units BTX-A reconstituted in 5 mL normal saline, injected into the bladder in 5 separate injections of 1 mL. One injection will be at the trigone * 100 units BTX-A reconstituted in 10 mL normal saline, injected into the bladder in 10 separate injections of 1 mL. One injection will be at the trigone The primary outcome will be measured on the day of the procedure using the NPS scale. Investigators will follow up with patients at 30 days post-procedure to assess treatment effectiveness, overall satisfaction, and post-procedure outcomes using validated questionnaires.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
BIOLOGICAL	Intradetrusor Botox Injections	100 units of OnabotuliumtoxinA is injected into the detrusor muscle in 1 mL aliquots using a cystoscope.

Timeline

• Start date: 2022-07-07
• Primary completion: 2023-04-06
• Completion: 2023-05-15
• First posted: 2022-12-15
• Last updated: 2025-04-13
• Results posted: 2025-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study