Overview

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.