Trans-gluteal Versus Trans-vaginal Pudendal Nerve Fluoroscopic Guided Pulsed Radiofrequency for Treatment of Superficial Dyspareunia: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- change in Numerical rating scale
研究概览
简要总结
Superficial dyspareunia represents a major health problem especially for the newly wed couples. Pulsed radiofrequency for pudendal nerve is a non-neurolytic neuromodulatory method that is effective in relief of this type of pain. Objectives: to evaluate the efficacy of bilateral pudendal nerve fluoroscopic guided pulsed radiofrequency in treatment of intractable non-organic dyspareunia, and compare between trans-gluteal and transvaginal approaches regarding patient comfort and satisfaction.
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)
入排标准
- 年龄范围
- 16 Years 至 46 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •women aged between 16 and 46 years and from a near vicinity to our facility to make her available for follow-up
排除标准
- •We had excluded women with any abnormality in the transvaginal US guided imagining, or those with any evidence of local gynecological abnormalities on examination. Meanwhile, we had excluded those women with infection at site of injection, coagulopathy or other bleeding diathesis, pre-existing neurologic deficit in the targeted region, those with history of chronic opioid use and women who refused to participate in the study
研究组 & 干预措施
trans-gluteal approach
received pudendal nerve pulsed radiofrequency through trans-gluteal approach
干预措施: pudendal nerve pulsed radiofrequency (Procedure)
trans-vaginal approach
received pudendal nerve pulsed radiofrequency through trans-vaginal approach
干预措施: pudendal nerve pulsed radiofrequency (Procedure)
结局指标
主要结局
change in Numerical rating scale
时间窗: baseline reading -1 day reading-3 days postoperative reading
0 no pain and 10 maximum pain
次要结局
未报告次要终点
研究者
Alaa Ali M. Elzohry
Clinical Professor
South Egypt Cancer Institute