NCT04270526

Minimizing Pain During Office Intradetrussor Botox Injection

Completed Phase 4 Results posted Last updated 6 March 2025

What this trial tests

Phase 4 trial testing Bicarbonate protocol in Overactive Bladder in 85 participants. Completed in 30 June 2023.

Timeline

15 August 2020

Primary endpoint
30 June 2023

30 June 2023

Quick facts

Lead sponsor	Boston Urogynecology Associates
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	85
Start date	15 August 2020
Primary completion	30 June 2023
Estimated completion	30 June 2023
Sites	1 location across United States

Drugs / interventions tested

• Bicarbonate protocol — full drug profile →
• Standard protocol — full drug profile →

Conditions studied

• Overactive Bladder — all drugs for Overactive Bladder →
• Overactive Detrusor — all drugs for Overactive Detrusor →
• Overactive Bladder Syndrome — all drugs for Overactive Bladder Syndrome →
• Overactivity; Behavior — all drugs for Overactivity; Behavior →

Sponsor

Boston Urogynecology Associates — full company profile →

Who can join

18 and older, female only, with Overactive Bladder or Overactive Detrusor. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pain: VAS Primary · Immediately after the procedure

Pain on visual analog scale from 0-100 with higher scores worse

Group	Value	95% CI
Active Treatment	25	15 – 55
Placebo Treatment	16	9 – 40

Satisfaction: Likert Scale Secondary · Immediately after the procedure

Likert scale questions assessing overall satisfaction with the procedure with responses from very 1 (dissatisfied) to 5 (very satisfied) with higher scores representing more satisfaction. We reported the percentage of participants who were satisfied we defined as a response of 4 or 5.

Group	Value	95% CI
Active Treatment	68
Placebo Treatment	39

Willingness to Undergo Repeat Procedure Secondary · Immediately after the procedure

Likert scale questions assessing the patient's willingness to undergo a repeat procedure from very likely (1) to very unlikely (5) with five items total. We defined willingness to undergo repeat procedure as a score of 1 or 2 on the Likert scale and outcome measured was the percentage of patients who responded with a 1 or 2.

Group	Value	95% CI
Active Treatment	72
Placebo Treatment	65

Sponsor's own description

This will be a prospective double-blinded randomized controlled trial comparing two pre-treatment protocols for patients undergoing intradetrussor botox injections to determine if a buffered lidocaine solution offers superior pain control.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.