At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 85 enrolled
Drug / intervention
Bicarbonate protocol +1 moredrug
Likely dose
Bicarbonate protocol 50 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Minimizing Pain During Office Intradetrussor Botox Injection: A Prospective Randomized Controlled Trial Comparing Two Protocols
In Brief
A Phase 4 clinical trial evaluating Bicarbonate protocol and Standard protocol for Overactive Bladder and 4 related conditions. Completed, enrolled 85 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOveractive Bladder, Overactive Detrusor, Overactive Bladder Syndrome, Overactivity; Behavior, Urge Incontinence
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
2020202120222023202420252026
First PostedFeb 2020
Enrollment StartAug 2020
Primary CompletionJun 2023
TodayJul 2026
First PostedFeb 17, 2020
Enrollment StartAug 15, 2020
Primary CompletionJun 30, 2023
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 6.4 years ago
Interventions
Bicarbonate protocoldrug
Intradetrussor treatment with 50 mL 1% lidocaine + 45ml of 0.9% normal saline + 5 mL 8.4% sodium bicarbonate
Standard protocoldrug
Intradetrussor treatment with 50 mL 1% lidocaine + 50ml of 0.9% normal saline