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NCT03847922 · ClinicalTrials.gov registry record · Phase 4
Nitrous Oxide for Analgesia During Office Urethral Bulking
A Phase 4 study, sponsored by Baylor Research Institute.
- Terminated
- Registry status
- Phase 4
- Development phase
- 2
- Enrollment target
NCT03847922: Clinical Trial Phase 4 study, sponsored by Baylor Research Institute.
NCT03847922 is a Phase 4 study that was terminated before completion, run by Baylor Research Institute. The registered enrollment target is 2 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03847922, a Phase 4 study, was terminated before completion, sponsored by Baylor Research Institute.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 2 participants
- Enrollment target
Study Summary
This study is designed to determine primarily if there is a difference in perceived pain in patients receiving urethral bulking with calcium hydroxylapatite using local lidocaine versus local lidocaine plus nitrous oxide gas. Patients will be randomized to a control group (local lidocaine plus room air) or a intervention group (local lidocaine plus 50% nitrous oxide/50% oxygen inhaled mixture). Their pain will be assessed immediately after the procedure, and their recollection of pain will also be assessed at their 2 week post-procedure visit. There are other secondary outcome measures as well; please see outcome measures section for full description.
Primary Outcome
Pain will be assessed both before the procedure upon enrollment immediately after the procedure using a 10cm visual analog scale (VAS), where patients will mark their pain level along the scale from "no pain" at 0cm to "pain as bad as it possibly could be" at 10cm; the change in pain score between the before and after procedure VASs (i.e. the baseline pain score subtracted from the post-procedure pain score) is the primary outcome
Interventions
- OTHER Room air
- DRUG Nitrous Oxide + Oxygen Gas (Product)
- DRUG lidocaine gel 2%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2019-02-15 |
| Est. Completion | 2020-07-23 |
| Phase | Phase 4 |
Why NCT03847922 stopped before completion
NCT03847922 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 3 interventions - of which Room air is the first listed.
NCT03847922 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03847922 about?
NCT03847922 is a clinical study titled "Nitrous Oxide for Analgesia During Office Urethral Bulking". This study is designed to determine primarily if there is a difference in perceived pain in patients receiving urethral bulking with calcium hydroxylapatite using local lidocaine versus local lidocaine plus nitrous oxide gas. Patients will be randomized to a control group (local lidocaine plus room ...
What is the current status of trial NCT03847922?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 2 participants. The study started on 2019-02-15. Estimated completion is 2020-07-23.
What interventions are being tested in trial NCT03847922?
The interventions under investigation include: Room air (OTHER), Nitrous Oxide + Oxygen Gas (Product) (DRUG), lidocaine gel 2% (DRUG).
Who is sponsoring clinical trial NCT03847922?
This trial is sponsored by Baylor Research Institute, which has 180 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03847922's enrollment target sits among peer trials
2 1998th of 2000 higher than 1 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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