NCT03847922

Nitrous Oxide for Analgesia During Office Urethral Bulking

Nitrous Oxide for Analgesia During Office Urethral Bulking: a Randomized, Controlled Trial

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Baylor Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain
• Stress Incontinence, Female

Interventions

Type	Name	Description
DRUG	Nitrous Oxide + Oxygen Gas (Product)	Self-administered 50% nitrous oxide / 50% oxygen mixture will be given to the intervention group, starting just before the beginning of the urethral bulking procedure.
DRUG	lidocaine gel 2%	6mL of 2% lidocaine gel will be inserted and injected into the urethral canal approximately 10 minutes prior to the procedure for each participant regardless of group assignment.
OTHER	Room air	Room air will be administered via the Pro-Nox machine to participants in the control group, starting just before the beginning of the urethral bulking procedure.

Timeline

• Start date: 2019-02-15
• Primary completion: 2020-07-23
• Completion: 2020-07-23
• First posted: 2019-02-20
• Last updated: 2020-08-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study