Nitrous Oxide for Analgesia During Office Urethral Bulking
Stopped early · Phase 4
Conditions studied: Pain, Stress Incontinence, Female
In brief
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.
Key facts
- Study ID
- NCT03847922
- Run by
- Baylor Research Institute
- People needed
- 2
- Starts
- 2019-02-15
- Expected to finish
- 2020-07-23
- Last updated by the study team
- 2020-08-20
Who can join
Age: 18 and older, up to 100. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- < 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.
Where it is running
- Baylor Scott and White Medical Center — Temple, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.