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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.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | lidocaine gel injected in the urethra 10 minutes prior to calcium hydroxylapatite injection plus self-administered room air |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret R Hines, MD | Baylor Scott and White Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Scott and White Medical Center | Temple | Texas | 76508 | United States |
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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| ID | Term |
|---|---|
| D010146 | Pain |
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014549 | Urinary Incontinence |
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| ID | Term |
|---|---|
| D009609 | Nitrous Oxide |
| D004364 | Pharmaceutical Preparations |
| ID | Term |
|---|---|
| D009589 | Nitrogen Oxides |
| D005740 | Gases |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
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Randomized controlled trial with patients randomized 1:1 into two groups
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Patients are blinded to their group assignment (they are not aware of whether they are receiving nitrous oxide or room air)
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| 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. |
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| 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. |
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| 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 |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D010087 |
| Oxides |
| D017601 | Oxygen Compounds |