Phase 4
N=76
Minimizing Pain During Office Intradetrussor Botox Injection
Overactive Bladder · Overactive Detrusor · Overactive Bladder Syndrome · Overactivity; Behavior · Urge Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT04270526 ↗Enrolled (actual)
76
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Pain: VAS — 25; 16 units on a scale, 0-100
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bicarbonate protocol (Drug); Standard protocol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Boston Urogynecology Associates
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain: VAS |
25; 16 | — |
| SECONDARY Satisfaction: Likert Scale |
68; 39 | — |
| SECONDARY Willingness to Undergo Repeat Procedure |
72; 65 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Female patient
- Primary diagnosis of overactive bladder
- Failed first and second line therapy for overactive bladder
- Planning to undergo bladder botox injections
Exclusion Criteria
- Neurogenic bladder
- Urinary retention
Data sourced from ClinicalTrials.gov (NCT04270526). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.