Nitrous Oxide for Analgesia During Office Urethral Bulking

• Status: Terminated
• Trial end date: 2020-07-23
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor Research Institute
• Treatments: Lidocaine; Nitrous Oxide

Criteria

Inclusion Criteria:

• Female patients

• greater than or equal to 18 years old

• with demonstrable stress incontinence on supine stress test

• undergoing calcium hydroxylapatite injection for urethral bulking for the first time

• able to consent to the study and procedure

Exclusion Criteria:

• < 18 years old

• prior urethral bulking therapy

• predominant urge incontinence symptoms

• contraindications to nitrous oxide

• pre-existing significant cardiopulmonary disease

• hypotension defined as systolic blood pressure (BP) < 90 or diastolic BP <50 on initial BP in the office

• chronic pain disorders (specifically fibromyalgia, chronic pelvic pain, sciatica or chronic low back pain, painful bladder syndrome)

• chronic narcotic use (defined as taking a narcotic medication >3 days per week during the past two weeks)

• pregnancy

• conditions of air trapping (bullous emphysema, bowel obstruction, pneumothorax, intracranial air, middle ear conditions, status post recent diving, recent eye surgery)

• lidocaine allergy

• neurologic diseases impairing pain perception.