Prevention of Postoperative Urinary Retention With Treatment of Tamsulosin 5 Days Prior to Lower Limb Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Occurrence of urinary retention
研究概览
简要总结
Various studies have shown that the risk of suffering a urinary retention after knee or hip prosthesis surgery is 10-80%. The aim of the study is to reduce this riks. For this purpose, it is investigated whether a previously known drug (tamsulosin) which is used in bladder emptying disorders, can achieve a reduction in urinary retention after surgery. After the patients agree to participate in the study, they are examined in our urological clinic. Uroflowmetry is performed with sonographic residual volume measurement and prostate volume measurement. Furthermore, a standardized Voiding questionaire (IPSS) is completed. This study is conducted as a double-blind study using a placebo control group. The drug / placebo is taken once a day, five days before and two days after surgery. Subsequently, it is observed whether it comes to a urinary retention or not. After the operation, no further urological checks are planned or needed.
详细描述
Study Category and rationale:
This study uses a well-known drug (tamsulosin) which is authorised in Switzerland and widely used to treat obstructive voiding problems. In our case the indication is different from that specified in the prescribing information, but it is within the same disease group, which in our case is to prevent urinary retention. Therefore according to the legal ordinance on clinical trials (ClinO), this study is classified as a clinical trial, research with collection of health-related personal data and placebo controlled of the category B.
Objective:
Our goal is to reduce the rate of postoperative urinary retention after lower limb arthroplasty. For this purpose, we plan to investigate whether an already known drug (Tamsulosin), which is widely used for bladder emptying disorders, could reduce the rate of postoperative urinary retention.
Outcomes:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blind.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •- male adults undergoing elective hip- or knee arthroplasty
排除标准
- •underage patients
- •pre-existing treatment with tamsulosin or other prostate affecting medication
- •patients who underwent transurethral resection of the prostate or prostatectomy
- •patients with urethral strictures
- •patients with neurological bladder dysfunction
- •Known allergy to tamsulosin
- •Hypotensive disorder
研究组 & 干预措施
Tamsulosin
The study specific product Tamsulosin 0.4mg, a tablet which is taken once a day per os five days prior to the operation and two days after the operation.
干预措施: Tamsulosin (Drug)
Placebo Oral Tablet
The placebo is taken once a day per os five days prior to the operation and two days after the operation.
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Occurrence of urinary retention
时间窗: 48 hours postoperatively
The primary outcome is the occurrence of urinary retention during the 48 postoperative hours.
次要结局
- Type of anaesthesia(48 hours postoperatively)
- Preoperative residual volume(Minimum 6 days before the planned operation.)
- Prostate size(Minimum 6 days before the planned operation.)
- International prostate symptom score (IPSS).(Minimum 6 days before the planned operation.)
研究者
PD Dr. med. Räto T. Strebel
Head of Urology
Kantonsspital Graubünden