Nitrous Oxide for Analgesia During Office Urethral Bulking: a Randomized, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change in pain
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Patients are blinded to their group assignment (they are not aware of whether they are receiving nitrous oxide or room air)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •< 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.
研究组 & 干预措施
Control group
lidocaine gel injected in the urethra 10 minutes prior to calcium hydroxylapatite injection plus self-administered room air
干预措施: lidocaine gel 2% (Drug)
Control group
lidocaine gel injected in the urethra 10 minutes prior to calcium hydroxylapatite injection plus self-administered room air
干预措施: Room air (Other)
Study group
lidocaine gel injected in the urethra 10 minutes prior to calcium hydroxylapatite injection + self-administered Pro-Nox 50% nitrous oxide/50% oxygen.
干预措施: Nitrous Oxide + Oxygen Gas (Product) (Drug)
Study group
lidocaine gel injected in the urethra 10 minutes prior to calcium hydroxylapatite injection + self-administered Pro-Nox 50% nitrous oxide/50% oxygen.
干预措施: lidocaine gel 2% (Drug)
结局指标
主要结局
Change in pain
时间窗: 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
次要结局
- Recollection of change in pain(10 minutes after the procedure)
- Procedure time(Intra-procedure)
- Change in Urogenital Distress Inventory (UDI-6) score(at enrollment and then again at the patient's 1-2 week post-procedure visit.)
- Change in Incontinence Severity Index (ISI) score(at enrollment and then again at the patient's 1-2 week post-procedure visit.)
- Patient Global Impression of Improvement (PGI-I) score(1-2 week post op visit)
- Adverse events(during the procedure)
- Blood pressure(during the procedure)
- Episodes of hypoxia(during the procedure)
- Episodes of bradycardia(during the procedure)
- Episodes of tachycardia(during the procedure)
- Patient's suspected group assignment(10 minutes after the procedure)