Nitrous Oxide for Analgesia During Office Urethral Bulking

Baylor Scott and White Health (BSWH)

Status and phase: Terminated; Phase 4

Conditions: Stress Incontinence, Female; Pain

Treatments: Drug: lidocaine gel 2%; Drug: Nitrous Oxide + Oxygen Gas (Product); Other: Room air

Study type: Interventional

Funder types: Other

Identifiers

NCT03847922

019-002

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

2 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

lidocaine gel injected in the urethra 10 minutes prior to calcium hydroxylapatite injection plus self-administered room air

Treatment:

Other: Room air

Drug: lidocaine gel 2%

Study group

Experimental group

Description:

lidocaine gel injected in the urethra 10 minutes prior to calcium hydroxylapatite injection + self-administered Pro-Nox 50% nitrous oxide/50% oxygen.

Treatment:

Drug: Nitrous Oxide + Oxygen Gas (Product)

Drug: lidocaine gel 2%