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NCT06695585 · ClinicalTrials.gov registry record · Phase 4
Optimal Intravesical Lidocaine Volume for Pain Relief During Office Intra-detrusor Onabotulinum Toxin a Injections
A Phase 4 study, sponsored by University of Louisville.
- Not yet
- Registry status
- Phase 4
- Development phase
- 36
- Enrollment target
NCT06695585: Clinical Trial Phase 4 study, sponsored by University of Louisville.
NCT06695585 is a Phase 4 study that has not yet begun recruiting, run by University of Louisville. The registered enrollment target is 36 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06695585, a Phase 4 study, has not yet begun recruiting, sponsored by University of Louisville.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 36 participants
- Enrollment target
Study Summary
The purpose of our study is to evaluate the efficacy and safety of different volumes of bladder-numbing medication for pain relief at the time of office bladder Botox injections. This is a randomized prospective, double-blind superiority trial comparing 200 ml 2% lidocaine versus 30 ml 2% lidocaine for office Botox injections.
Primary Outcome
a. Determine the efficacy of pain relief via the Visual Analog Scale (VAS, scored 0-100 on 100 mm scale with 0 indicating no pain and 100 indicating the worst pain possible) in women randomized to 200 ml 2% lidocaine without epinephrine versus 30 ml 2% lidocaine without epinephrine prior to office intravesical onabotulinum toxin A (Botox) injections i. Perceived maximum VAS during the procedure and post-procedure ii. Superiority limit 20 mm on 100 mm VAS scale
Interventions
- DRUG Lidocaine 2% without vessel constrictor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2024-12-01 |
| Est. Completion | 2025-12-01 |
| Phase | Phase 4 |
What is known before NCT06695585 opens enrollment
NCT06695585 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Lidocaine 2% without vessel constrictor is the first listed.
NCT06695585 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06695585 about?
NCT06695585 is a clinical study titled "Optimal Intravesical Lidocaine Volume for Pain Relief During Office Intra-detrusor Onabotulinum Toxin a Injections". The purpose of our study is to evaluate the efficacy and safety of different volumes of bladder-numbing medication for pain relief at the time of office bladder Botox injections. This is a randomized prospective, double-blind superiority trial comparing 200 ml 2% lidocaine versus 30 ml 2% lidocaine ...
What is the current status of trial NCT06695585?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 36 participants. The study started on 2024-12-01. Estimated completion is 2025-12-01.
What interventions are being tested in trial NCT06695585?
The interventions under investigation include: Lidocaine 2% without vessel constrictor (DRUG).
Who is sponsoring clinical trial NCT06695585?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06695585's enrollment target sits among peer trials
36 1490th of 2000 higher than 495 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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