Nitrous Oxide for Analgesia During Office Urethral Bulking

Nitrous Oxide for Analgesia During Office Urethral Bulking: a Randomized, Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Pain; Stress Incontinence, Female
• Intervention / Treatment: Drug: lidocaine gel 2%; Other: Room air; Drug: Nitrous Oxide + Oxygen Gas (Product)

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Temple, Texas, United States, 76508
      • Baylor Scott and White Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Control group; lidocaine gel injected in the urethra 10 minutes prior to calcium hydroxylapatite injection plus self-administered room air	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.; Other Names: Uro-Jet; Other: 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.
EXPERIMENTAL: Study group; lidocaine gel injected in the urethra 10 minutes prior to calcium hydroxylapatite injection + self-administered Pro-Nox 50% nitrous oxide/50% oxygen.	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.; Other Names: Uro-Jet; Drug: 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.; Other Names: Pro-Nox

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recollection of change in pain	Recollection of pain measured by a 10cm visual analog scale (VAS) completed 10 minutes after the procedure; this will be compared to the baseline pain score on VAS from prior to the procedure, again to determine the patient's perceived change in pain during the procedure. The VAS used has patients mark their pain level along the scale from "no pain" at 0cm to "pain as bad as it possibly could be" at 10cm. The score on the VAS at baseline is subtracted from the score on the VAS at 10 minutes to get the change in pain as the patient remembered it.	10 minutes after the procedure
Procedure time	Time from the initial insertion of the cystoscope (for the injection of calcium hydroxylapatite) to final removal of the cystoscope	Intra-procedure
Change in Urogenital Distress Inventory (UDI-6) score	A change in the patient's UDI-6 score, measured prior to procedure and then again at the 1-2 week post-procedure visit. UDI-6 is a measure of the severity of urinary symptoms the patient experiences, with minimum score of 0 (indicating no bother from urinary symptoms) and maximum score of 100 (indicating maximum bother from urinary symptoms). We will be assessing the change in this score from baseline, by subtracting the post-procedure score at 1-2 weeks from the baseline score.	at enrollment and then again at the patient's 1-2 week post-procedure visit.
Change in Incontinence Severity Index (ISI) score	A change in the patient's ISI score, measured prior to procedure and then again at the 1-2 week post-procedure visit. ISI score measures severity of incontinence symptoms on a scale of 0 to 12, where 0 is no symptoms and 12 is maximal incontinence symptoms. We will calculate the change in score by subtracting the post-procedure score at 1-2 weeks from the baseline score.	at enrollment and then again at the patient's 1-2 week post-procedure visit.
Patient Global Impression of Improvement (PGI-I) score	Score on PGI-I at the patient's 1-2 week post-procedure visit. This score assesses who the patient feels their post-procedure condition is compared to prior to the procedure on a scale of 1-7, where 1 is "very much better" and 7 is "very much worse."	1-2 week post op visit
Adverse events	apneic episodes > 15 seconds, patient lack of responsiveness, patient dissociative behavior, hypotension with blood pressure < 90/50, bradycardia < 50bpm, hypoxia with oxygen saturation <92% on pulse oximetry, significant nausea or vomiting	during the procedure
Blood pressure	We will record blood pressure every 5 minutes during the procedure	during the procedure
Episodes of hypoxia	We will record any oxygen saturation < 92% during the procedure	during the procedure
Episodes of bradycardia	We will record any episodes of heart rate < 60bpm during the procedure	during the procedure
Episodes of tachycardia	We will record episodes of heart rate > 100bpm during the procedure	during the procedure
Patient's suspected group assignment	10 minutes after the procedure, the patients will be asked to which treatment arm they suspected they were allocated	10 minutes after the procedure

Collaborators and Investigators

• Sponsor: Baylor Research Institute
• Investigators: Principal Investigator: Margaret R Hines, MD, Baylor Scott and White Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 15, 2019
• Primary Completion (ACTUAL): July 23, 2020
• Study Completion (ACTUAL): July 23, 2020

Study Registration Dates

• First Submitted: February 18, 2019
• First Submitted That Met QC Criteria: February 19, 2019
• First Posted (ACTUAL): February 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 20, 2020
• Last Update Submitted That Met QC Criteria: August 18, 2020
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Urinary Incontinence, Stress; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Anesthetics, Inhalation; Lidocaine; Nitrous Oxide
• Other Study ID Numbers: 019-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be shared with other researchers. Once all data is collected for a specific patient, it will be deidentified and entered in a spread sheet to be used for this study only.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes