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Nitrous Oxide for Analgesia During Office Urethral Bulking

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ClinicalTrials.gov Identifier: NCT03847922
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Margaret Hines, Baylor Research Institute

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.

Condition or disease Intervention/treatment Phase
Pain Stress Incontinence, Female Drug: Nitrous Oxide + Oxygen Gas (Product) Drug: lidocaine gel 2% Other: Room air Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial with patients randomized 1:1 into two groups
Masking: Single (Participant)
Masking Description: Patients are blinded to their group assignment (they are not aware of whether they are receiving nitrous oxide or room air)
Primary Purpose: Treatment
Official Title: Nitrous Oxide for Analgesia During Office Urethral Bulking: a Randomized, Controlled Trial
Actual Study Start Date : February 15, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


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 Name: 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: 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 Name: Pro-Nox

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 Name: Uro-Jet




Primary Outcome Measures :
  1. Change in pain [ Time Frame: upon enrollment and immediately after the procedure ]
    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


Secondary Outcome Measures :
  1. Recollection of change in pain [ Time Frame: 10 minutes after the procedure ]
    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.

  2. Procedure time [ Time Frame: Intra-procedure ]
    Time from the initial insertion of the cystoscope (for the injection of calcium hydroxylapatite) to final removal of the cystoscope

  3. Change in Urogenital Distress Inventory (UDI-6) score [ Time Frame: at enrollment and then again at the patient's 1-2 week post-procedure visit. ]
    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.

  4. Change in Incontinence Severity Index (ISI) score [ Time Frame: at enrollment and then again at the patient's 1-2 week post-procedure visit. ]
    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.

  5. Patient Global Impression of Improvement (PGI-I) score [ Time Frame: 1-2 week post op visit ]
    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."

  6. Adverse events [ Time Frame: during the procedure ]
    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

  7. Blood pressure [ Time Frame: during the procedure ]
    We will record blood pressure every 5 minutes during the procedure

  8. Episodes of hypoxia [ Time Frame: during the procedure ]
    We will record any oxygen saturation < 92% during the procedure

  9. Episodes of bradycardia [ Time Frame: during the procedure ]
    We will record any episodes of heart rate < 60bpm during the procedure

  10. Episodes of tachycardia [ Time Frame: during the procedure ]
    We will record episodes of heart rate > 100bpm during the procedure

  11. Patient's suspected group assignment [ Time Frame: 10 minutes after the procedure ]
    10 minutes after the procedure, the patients will be asked to which treatment arm they suspected they were allocated



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03847922


Contacts
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Contact: Margaret R Hines, MD 254-724-7573 margaret.hines@bswhealth.org

Locations
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United States, Texas
Baylor Scott and White Medical Center Recruiting
Temple, Texas, United States, 76508
Contact: Margaret R Hines, MD    254-724-7573    margaret.hines@bswhealth.org   
Principal Investigator: Margaret R Hines, MD         
Principal Investigator: Jill Danford, MD         
Principal Investigator: Erin Bird, MD         
Principal Investigator: Thomas Kuehl, PhD         
Sponsors and Collaborators
Baylor Research Institute
Investigators
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Principal Investigator: Margaret R Hines, MD Baylor Scott and White Health

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Responsible Party: Margaret Hines, FPMRS Fellow, Baylor Research Institute
ClinicalTrials.gov Identifier: NCT03847922     History of Changes
Other Study ID Numbers: 019-002
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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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

Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Urinary Incontinence, Stress
Urinary Incontinence
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Lidocaine
Nitrous Oxide
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anesthetics, Inhalation
Anesthetics, General
Analgesics, Non-Narcotic
Analgesics