Nitrous Oxide for Analgesia During Office Urethral Bulking

NCT ID: NCT03847922

Last Updated: 2020-08-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-15
• Study Completion Date: 2020-07-23

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.

Conditions

Pain; Stress Incontinence, Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

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

Group Type: PLACEBO_COMPARATOR

lidocaine gel 2%

Intervention Type: DRUG

6mL of 2% lidocaine gel will be inserted and injected into the urethral canal approximately 10 minutes prior to the procedure for each participant regardless of group assignment.

Room air

Intervention Type: OTHER

Room air will be administered via the Pro-Nox machine to participants in the control group, starting just before the beginning of the urethral bulking procedure.

Study group

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

Group Type: EXPERIMENTAL

Nitrous Oxide + Oxygen Gas (Product)

Intervention Type: DRUG

Self-administered 50% nitrous oxide / 50% oxygen mixture will be given to the intervention group, starting just before the beginning of the urethral bulking procedure.

lidocaine gel 2%

Intervention Type: DRUG

6mL of 2% lidocaine gel will be inserted and injected into the urethral canal approximately 10 minutes prior to the procedure for each participant regardless of group assignment.

Interventions

Nitrous Oxide + Oxygen Gas (Product)

Self-administered 50% nitrous oxide / 50% oxygen mixture will be given to the intervention group, starting just before the beginning of the urethral bulking procedure.

Intervention Type: DRUG

lidocaine gel 2%

6mL of 2% lidocaine gel will be inserted and injected into the urethral canal approximately 10 minutes prior to the procedure for each participant regardless of group assignment.

Intervention Type: DRUG

Room air

Room air will be administered via the Pro-Nox machine to participants in the control group, starting just before the beginning of the urethral bulking procedure.

Intervention Type: OTHER

Other Intervention Names

Pro-Nox; Uro-Jet

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Baylor Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margaret R Hines, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor Scott and White Health

Locations

Baylor Scott and White Medical Center

Temple, Texas, United States

Countries

United States

Other Identifiers

019-002

Identifier Type: -

Identifier Source: org_study_id