NCT05687019已完成不适用
Efficacy of Hyaluronic Acid and Chondroitin Sulphate in Intravesical Injections on Functional Recovery After Holmium Laser Surgery for Prostate Adenoma (HOLEP-AHCS)
GCS Ramsay Santé pour l'Enseignement et la Recherche2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2023年9月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- International Prostate Score Symptom on Day 28
研究概览
简要总结
The purpose of this study is to evaluate the score on urinary function (International Prostate Score Symptom) at 28 days.
The main objective is to assess the efficacy of treatment with Ialuril® Prefill on functional recovery at 4 weeks, based on the International Prostate Score Symptom.
A paired test will be performed to compare the International Prostate Score Symptom score between 0 and 28 days.
详细描述
This is an interventional, non-comparative, open-label, monocentric study aimed at evaluating treatment with hyaluronic acid in patients who have undergone surgery (HOLEP procedure) for prostatic adenoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient eligible for a HOLEP procedure, according to the investigator ;
- •Patient able to understand the information related to the clinical investigation, to read the information leaflet and agrees to sign the consent form.
排除标准
- •Known intolerance to one of the treatment components: hyaluronic acid, chondroitin sulphate, calcium chloride;
- •Prostatic volume greater than 140 cm3;
- •Patient under anticoagulant treatment for secondary prevention;
- •Patient under guardianship or curatorship, or under a regime of deprivation of liberty;
- •Participating patient, or in a period of exclusion from another clinical trial;
- •Patient not benefiting from a social security scheme.
结局指标
主要结局
International Prostate Score Symptom on Day 28
时间窗: 28 days
次要结局
未报告次要终点
研究者
研究点 (2)
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