Status:
TERMINATED
Nitrous Oxide for Analgesia During Office Urethral Bulking
Lead Sponsor:
Baylor Research Institute
Conditions:
Pain
Stress Incontinence, Female
Eligibility:
FEMALE
18-100 years
Phase:
PHASE4
Brief 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 lidocain...
Eligibility Criteria
Inclusion
- 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
- \< 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.
Key Trial Info
Start Date :
February 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 23 2020
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03847922
Start Date
February 15 2019
End Date
July 23 2020
Last Update
August 20 2020
Active Locations (1)
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1
Baylor Scott and White Medical Center
Temple, Texas, United States, 76508