跳至主要内容
临床试验/jRCTs052230106
jRCTs052230106招募中不适用

The utility of penile rehabilitation with vacuum constriction device after performing brachytherapy for prostate cancer. (VIGOR Study)

未提供0 个研究点目标入组 30 人开始时间: 2024年6月5日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
30
主要终点
-

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Single Arm Study
干预模型
Single Assignment
主要目的
Prevention Purpose
盲法
Open(masking Not Used)

入排标准

年龄范围
20age old over 至 75age old under(—)
性别
Male

入选标准

  • Disease: Prostate cancer
  • Stage: Stage 1-2
  • Age: 20-75 years old
  • Gender: Male
  • ECOG PS (Performance Status) 0-1
  • Mild to moderately preserved sexual function before brachytherapy (SHIM more than 12 points)
  • Patients treated with brachytherapy alone
  • Patients planning to have sexual intercourse before or after surgery
  • Patients who have given written consent to participate in this clinical study

排除标准

  • Patients with cognitive impairment
  • Patients with poorly controlled diabetes mellitus (HbA1c of 10% or higher)
  • Patients with neurological disease
  • Patients undergoing adjuvant hormonal therapy (surgical castration or medical castration) for brachytherapy
  • Patients receiving external radiation therapy as adjuvant therapy to brachytherapy
  • Patients taking PDE5 inhibitors
  • Patients using vacuum constriction device
  • Patients on antithrombotic therapy or predisposed to bleeding
  • Patients who have difficulty operating vacuum constriction device
  • Patients who are deemed inappropriate as research subjects by the principal investigator or subinvestigator

结局指标

主要结局

-

SHIM score at 6 months after brachytherapy

次要结局

未报告次要终点

研究者

发起方
未提供

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