The Use of Temporarily Implanted Nitinol Device (iTind) System in Chinese Male Patients With Lower Urinary Tract Symptom Secondary to Benign Prostate Enlargement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Changes in International Prostate Symptom Score (IPSS) at 6 months after treatment score
研究概览
简要总结
This is a prospective series of consecutive cases of patients undergoing iTind for the treatment of male LUTS.
详细描述
This is a prospective series of consecutive cases of patients undergoing iTind for the treatment of male LUTS.The procedure was carried out using perioperative antibiotic prophylaxis, according to the local culture and sensitivity profile. Patient will be discharged and readmitted 7 days for device removal under local anaesthesia transurethrally. After the device is removed and patients will be monitor for any problem in voiding or haematuria, and then discharged. Subjects will be follow-up at 3-, 6, 12- months after treatment.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged between 50 - 80 years
- •Clinically indicated for surgical treatment
- •Prostate volume of 25 to 75 cc
排除标准
- •Patients with active urinary tract infection or in retention of urine
- •Patients with bleeding disorder or on anti-coagulation
- •Patients with bladder pathology including bladder stone and bladder cancer
- •Patients with urethral stricture
- •Patients with neurogenic bladder and/or sphincter abnormalities
- •Patients with previous nonpharmacological prostate treatment,
- •Prostate cancer
- •Fail to give informed consent
结局指标
主要结局
Changes in International Prostate Symptom Score (IPSS) at 6 months after treatment score
时间窗: Baseline and 6 months
Change in total scores in International Prostate Symptom Score (ranges from 0 to 35) questionnaires.The higher score the more worse symptom.
次要结局
- International Prostate Symptom Score (IPSS) questionnaire QoL Score(Baseline, 3 months, 6 months and 12 months)
- 30-day complications after study intervention(at 30 days after study intervention)
- Total score in IPSS questionnaire after study intervention(Baseline, 3 months, 6 months and 12 months)
- Overactive bladder symptom score (OABSS) questionnaire total score(Baseline, 3 months, 6 months and 12 months)
- Pain Score(Immediately after study intervention and 1 wee after study intervention)
- Urodynamic function assessed by uroflowmetry parameter(Baseline, 3 months, 6 months and 12 months)
研究者
NG Chi Fai
Professor
Chinese University of Hong Kong