NCT06043063终止不适用
Post-procedural Pain Associated With Periurethral Block at Time of Bulkamid Injection for SUI: a Randomized Controlled Trial
Medstar Health Research Institute6 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2023年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 23
- 试验地点
- 6
- 主要终点
- Visual analog scale (VAS) for pain
研究概览
简要总结
While recommended pre-anesthesia for polyacylamide hydrogel (PAHG, Bulkamid) injections for stress urinary incontinence and intrinsic sphincter deficiency can include intraurethral anesthetic gel with or without periurethral block, there is no existing literature to guide choice of anesthesia. This is a single-blinded randomized control trial to evaluate post-procedure pain with choice of anesthesia before PAHG injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ≥ 18 years old with stress urinary incontinence, intrinsic sphincter deficiency, or stress-predominant mixed urinary incontinence desiring PAHG
- •English-speaking
- •Scheduled in outpatient clinic or OR without sedation, general, or neuraxial anesthesia
排除标准
- •Pregnancy
- •Neurogenic bladder
- •Pre-existing need for intermittent catheterization or indwelling catheter
- •Bladder or urothelial malignancy
- •Prior radiation to pelvic floor
- •Known allergy/sensitivity to PAHG
结局指标
主要结局
Visual analog scale (VAS) for pain
时间窗: Ascertained at end of procedure (withdrawal of cystoscope)
Visual analog scale for pain uses a scale from 0-10 corresponding to reported pain levels with 0 indicating no pain and 10 indicating most severe pain possible
次要结局
- Duration of procedure(Ascertained at end of procedure (within 5 minutes of withdrawal of cystoscope))
- Need for re-injection of PAHG(Assessed at follow-up 2 weeks post-procedure)
- Patient Global Impression of Improvement scale (PGI-I)(Assessed at two-week and twelve-week follow-up visit)
- Incomplete bladder emptying(Ascertained on day-of-procedure (within 1 hour of withdrawal of cystoscope))
- International Consultation on Incontinence Questionnaire for Urinary Incontinence (ICIQ-UI)(Assessed at baseline and at two-week and twelve-week follow-up visit)
研究者
研究点 (6)
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