Clinical trial NCT03847922: Nitrous Oxide for Analgesia During Office Urethral Bulking
Official title: Nitrous Oxide for Analgesia During Office Urethral Bulking: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain
Stress Incontinence, Female
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with patients randomized 1:1 into two groups
Primary purpose: TREATMENT

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 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.


Eligibility 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.

Primary outcomes:
measure: Change in pain
timeFrame: upon enrollment and immediately after the procedure
Secondary outcomes:
measure: Recollection of change in pain
timeFrame: 10 minutes after the procedure
measure: Procedure time
timeFrame: Intra-procedure
measure: Change in Urogenital Distress Inventory (UDI-6) score
timeFrame: at enrollment and then again at the patient's 1-2 week post-procedure visit.
measure: Change in Incontinence Severity Index (ISI) score
timeFrame: at enrollment and then again at the patient's 1-2 week post-procedure visit.
measure: Patient Global Impression of Improvement (PGI-I) score
timeFrame: 1-2 week post op visit
measure: Adverse events
timeFrame: during the procedure
measure: Blood pressure
timeFrame: during the procedure
measure: Episodes of hypoxia
timeFrame: during the procedure
measure: Episodes of bradycardia
timeFrame: during the procedure
measure: Episodes of tachycardia
timeFrame: during the procedure
measure: Patient's suspected group assignment
timeFrame: 10 minutes after the procedure
Other outcomes:
Locations:
city: Temple
country: United States
facility: Baylor Scott and White Medical Center
state: Texas
Study officials:
affiliation: Baylor Scott and White Health
name: Margaret R Hines, MD
role: PRINCIPAL_INVESTIGATOR
References: