Nitrous Oxide for Analgesia During Office Urethral Bulking

Phase 4TerminatedNCT03847922

Baylor Research Institute2 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Pain Stress Incontinence, Female

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: upon enrollment and immediately after the procedure

Secondary Outcomes

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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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."

Time frame: 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