Nitrous Oxide for Analgesia During Office Urethral Bulking

NCT03847922 | Terminated Phase 4 FDA Drug

• 1 other identifier: 019-002
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in pain

  Pain will be assessed both before the procedure upon enrollment immediately after the procedure using a 10cm visual analog scale (VAS), where patients will mark their pain level along the scale from "no pain" at 0cm to "pain as bad as it possibly could be" at 10cm; the change in pain score between the before and after procedure VASs (i.e. the baseline pain score subtracted from the post-procedure pain score) is the primary outcome

  upon enrollment and immediately after the procedure

Secondary Outcomes (11)

• Recollection of change in pain

  10 minutes after the procedure

• Procedure time

  Intra-procedure

• Change in Urogenital Distress Inventory (UDI-6) score

  at enrollment and then again at the patient's 1-2 week post-procedure visit.

• Change in Incontinence Severity Index (ISI) score

  at enrollment and then again at the patient's 1-2 week post-procedure visit.

• Patient Global Impression of Improvement (PGI-I) score

  1-2 week post op visit

Study Arms (2)

Control group

PLACEBO COMPARATOR

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

Drug: lidocaine gel 2%; Other: Room air

Study group

EXPERIMENTAL

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

Drug: Nitrous Oxide + Oxygen Gas (Product); Drug: lidocaine gel 2%

Interventions

Nitrous Oxide + Oxygen Gas (Product) 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.

Also known as: Pro-Nox

Study group

lidocaine gel 2% 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.

Also known as: Uro-Jet

Control group; Study group

Room air 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.

Control group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Scott and White Medical Center

Temple, Texas, 76508, United States

Location

MeSH Terms

Conditions

Pain; Urinary Incontinence, Stress

Interventions

Nitrous Oxide; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds

Study Officials

• Margaret R Hines, MD

  Baylor Scott and White Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients are blinded to their group assignment (they are not aware of whether they are receiving nitrous oxide or room air)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial with patients randomized 1:1 into two groups

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: February 20, 2019
• Study Start: February 15, 2019
• Primary Completion: July 23, 2020
• Study Completion: July 23, 2020
• Last Updated: August 20, 2020

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)