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PainPhase 4NCT03847922

Nitrous Oxide for Analgesia During Office Urethral Bulking

A Phase 4 study testing Nitrous Oxide + Oxygen Gas (Product), lidocaine gel 2% and Room air in people with Pain and Stress Incontinence, Female, run by Baylor Research Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years, women only
Conditions the study is for
Pain, Stress Incontinence, Female
What is being tested?
Nitrous Oxide + Oxygen Gas (Product), lidocaine gel 2% and Room air
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2 participants
Where
1 siteUnited States
Study dates
15 Feb 2019to 23 Jul 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • < 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Baylor Scott and White Medical Center

    Temple, Texas, 76508

Other trials in United States

About this study

Official title: 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.

Being tested
Nitrous Oxide + Oxygen Gas (Product), lidocaine gel 2%, Room air
Medical subject headings
Pain, Urinary Incontinence, Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nitrous Oxide + Oxygen Gas (Product)Drug

    Also called Pro-Nox

    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%Drug

    Also called Uro-Jet

    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 airOther

    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 groups in NCT03847922
Study groupRoleWhat they receive
Control groupPlacebo comparatorlidocaine gel injected in the urethra 10 minutes prior to calcium hydroxylapatite injection plus self-administered room air
Receives: Drug: lidocaine gel 2%; Other: Room air
Study groupExperimentallidocaine gel injected in the urethra 10 minutes prior to calcium hydroxylapatite injection + self-administered Pro-Nox 50% nitrous oxide/50% oxygen.
Receives: Drug: Nitrous Oxide + Oxygen Gas (Product); Drug: lidocaine gel 2%

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: upon enrollment and immediately after the procedure

Secondary outcomes (11)

  1. 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.

    Measured: 10 minutes after the procedure

  2. Procedure time

    Time from the initial insertion of the cystoscope (for the injection of calcium hydroxylapatite) to final removal of the cystoscope

    Measured: Intra-procedure

  3. 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.

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

  4. 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.

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

  5. 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."

    Measured: 1-2 week post op visit

  6. 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

    Measured: during the procedure

  7. Blood pressure

    We will record blood pressure every 5 minutes during the procedure

    Measured: during the procedure

  8. Episodes of hypoxia

    We will record any oxygen saturation < 92% during the procedure

    Measured: during the procedure

  9. Episodes of bradycardia

    We will record any episodes of heart rate < 60bpm during the procedure

    Measured: during the procedure

  10. Episodes of tachycardia

    We will record episodes of heart rate > 100bpm during the procedure

    Measured: during the procedure

  11. Patient's suspected group assignment

    10 minutes after the procedure, the patients will be asked to which treatment arm they suspected they were allocated

    Measured: 10 minutes after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2019
  2. Study start15 Feb 2019
  3. Primary completion23 Jul 2020
  4. Study completion23 Jul 2020

Why it 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial with patients randomized 1:1 into two groups
Masking
Single blind
Who is masked
Participant
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03847922
Sponsor's protocol ID
019-002
Status last verified
Feb 2019
First submitted
18 Feb 2019
Last updated
20 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nitrous Oxide + Oxygen Gas (Product), lidocaine gel 2% and Room air in people with Pain and Stress Incontinence, Female, run by Baylor Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: 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.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in pain (time frame: upon enrollment and immediately after the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03847922.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2020.

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