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Nitrous Oxide for Analgesia During Office Urethral Bulking

Primary Purpose

Pain, Stress Incontinence, Female

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nitrous Oxide + Oxygen Gas (Product)
lidocaine gel 2%
Room air
Sponsored by
Baylor Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Baylor Scott and White Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control group

Study group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Procedure time
Time from the initial insertion of the cystoscope (for the injection of calcium hydroxylapatite) to final removal of the cystoscope
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.
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.
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."
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
Blood pressure
We will record blood pressure every 5 minutes during the procedure
Episodes of hypoxia
We will record any oxygen saturation < 92% during the procedure
Episodes of bradycardia
We will record any episodes of heart rate < 60bpm during the procedure
Episodes of tachycardia
We will record episodes of heart rate > 100bpm 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

Full Information

First Posted
February 18, 2019
Last Updated
August 18, 2020
Sponsor
Baylor Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03847922
Brief Title
Nitrous Oxide for Analgesia During Office Urethral Bulking
Official Title
Nitrous Oxide for Analgesia During Office Urethral Bulking: a Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Due to staffing changes in the hospital, we will be unable to complete this study for the requested 84 subjects. As such, we have decided to close this study.
Study Start Date
February 15, 2019 (Actual)
Primary Completion Date
July 23, 2020 (Actual)
Study Completion Date
July 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor Research Institute

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Stress Incontinence, Female

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial with patients randomized 1:1 into two groups
Masking
Participant
Masking Description
Patients are blinded to their group assignment (they are not aware of whether they are receiving nitrous oxide or room air)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
lidocaine gel injected in the urethra 10 minutes prior to calcium hydroxylapatite injection plus self-administered room air
Arm Title
Study group
Arm Type
Experimental
Arm Description
lidocaine gel injected in the urethra 10 minutes prior to calcium hydroxylapatite injection + self-administered Pro-Nox 50% nitrous oxide/50% oxygen.
Intervention Type
Drug
Intervention Name(s)
Nitrous Oxide + Oxygen Gas (Product)
Other Intervention Name(s)
Pro-Nox
Intervention Description
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
Intervention Name(s)
lidocaine gel 2%
Other Intervention Name(s)
Uro-Jet
Intervention Description
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
Other
Intervention Name(s)
Room air
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in pain
Description
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
Time Frame
upon enrollment and immediately after the procedure
Secondary Outcome Measure Information:
Title
Recollection of change in pain
Description
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.
Time Frame
10 minutes after the procedure
Title
Procedure time
Description
Time from the initial insertion of the cystoscope (for the injection of calcium hydroxylapatite) to final removal of the cystoscope
Time Frame
Intra-procedure
Title
Change in Urogenital Distress Inventory (UDI-6) score
Description
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.
Time Frame
at enrollment and then again at the patient's 1-2 week post-procedure visit.
Title
Change in Incontinence Severity Index (ISI) score
Description
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.
Time Frame
at enrollment and then again at the patient's 1-2 week post-procedure visit.
Title
Patient Global Impression of Improvement (PGI-I) score
Description
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."
Time Frame
1-2 week post op visit
Title
Adverse events
Description
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
Time Frame
during the procedure
Title
Blood pressure
Description
We will record blood pressure every 5 minutes during the procedure
Time Frame
during the procedure
Title
Episodes of hypoxia
Description
We will record any oxygen saturation < 92% during the procedure
Time Frame
during the procedure
Title
Episodes of bradycardia
Description
We will record any episodes of heart rate < 60bpm during the procedure
Time Frame
during the procedure
Title
Episodes of tachycardia
Description
We will record episodes of heart rate > 100bpm during the procedure
Time Frame
during the procedure
Title
Patient's suspected group assignment
Description
10 minutes after the procedure, the patients will be asked to which treatment arm they suspected they were allocated
Time Frame
10 minutes after the procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret R Hines, MD
Organizational Affiliation
Baylor Scott and White Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor Scott and White Medical Center
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

Nitrous Oxide for Analgesia During Office Urethral Bulking

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