NCT06558539尚未招募3 期
Study on the Efficacy of Wearable Transcutaneous Tibial Nerve Stimulation for Persistent Overactive Bladder Symptoms Post Benign Prostatic Hyperplasia Surgery
Qing Yuan0 个研究点目标入组 90 人开始时间: 2024年9月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- Average Daily Urination Frequency Compared to Baseline
研究概览
简要总结
A single-center, randomized, parallel-controlled design. Approximately 90 cases of persistent overactive bladder symptoms post benign prostatic hyperplasia surgery are expected to be enrolled. The study participants will be randomly assigned to three groups, with 30 participants in each group.
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
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •1. Patients with overactive bladder before benign prostatic hyperplasia 2.Overactive bladder still exists 1 month after the operation of benign prostatic hyperplasia; 3.50 ≤ age ≤80 , male 4.72-hour urination diary showed an average of ≥8 urination times every 24 hours at baseline
排除标准
- 未提供
结局指标
主要结局
Average Daily Urination Frequency Compared to Baseline
时间窗: treatment during 12 weeks : assessments at weeks 4, 8, and 12.
At the end of Weeks 4, 8, and 12, the change in average daily urination frequency compared to baseline will be calculated using the participants' 72-hour voiding diaries
次要结局
- Average Daily Nocturia Frequency Compared to Baseline(treatment during 12 weeks : assessments at weeks 4, 8, and 12.)
- Average Voided Volume per Urination Compared to Baseline(treatment during 12 weeks : assessments at weeks 4, 8, and 12.)
- Average Urinary Urgency Score(treatment during 12 weeks : assessments at weeks 4, 8, and 12.)
- SAS Compared to Baseline(treatment during 12 weeks : assessments at weeks 4, 8, and 12.)
- Potential Adverse Events Related by TTNS(Entire Study)
- Average Daily Incontinence Episodes(treatment during 12 weeks : assessments at weeks 4, 8, and 12.)
- AUA-SI-QOL Compared to Baseline(treatment during 12 weeks : assessments at weeks 4, 8, and 12.)
- OABSS Compared to Baseline(treatment during 12 weeks : assessments at weeks 4, 8, and 12.)
- PPBC-S Compared to Baseline(treatment during 12 weeks : assessments at weeks 4, 8, and 12.)
- Participant Satisfaction(treatment during 12 weeks : assessments at weeks 4, 8, and 12.)
研究者
Qing Yuan
Associate Chief Physician of Urology
Chinese PLA General Hospital
相似试验
Unknown
不适用
taVNS Paired With Motor Training for Upper-extremity Rehabilitation in Stroke PatientsUpper Extremity DysfunctionStrokeNCT05943431Qiuyou Xie150
已完成
不适用
Transcutaneous Electrical Nerve Stimulation (TENS) for IUD Insertion PainPainNCT06245655Icahn School of Medicine at Mount Sinai99
已完成
2 期
Treating Depression With Transcutaneous Electrical Cranial-auricular Acupoint Stimulation (TECAS).Mild-to-moderate DepressionNCT03909217The University of Hong Kong470
招募中
不适用
Transcutaneous Electrical Acustimulation in the Treatment of Mild to Moderate Ulcerative ColitisUlcerative ColitisNCT06231264Xijing Hospital96
招募中
不适用
Electrical Stimulation for Vision Neuroenhancement in GlaucomaGlaucomaGlaucoma Open-AngleNCT06685211Stanford University30