Prophylactic Tamsulosin in Prevention of Post-operative Urinary Retention in Men After Transanal Endoscopic Microsurgery: A Multicenter Randomized, Double-blind, Placebo-controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 158
- 试验地点
- 3
- 主要终点
- Post-Operative Urinary Retention (POUR) (yes or no)
研究概览
简要总结
Post-operative urinary retention (POUR) is a frequent complication reported as ranging from 10 to 55% in the literature. In a recent retrospective study from Laliberte et al in Quebec City, we observed that 19% of the patients operated using transanal endoscopic microsurgery (TEM) had a post-operative urinary retention (POUR). Factors related to the patient, the tumor and the surgery were not observed to be associated risk factors. Tamsulosin has been shown as an effective preventive agent of POUR for certain ano-rectal and inguinal surgeries. The efficacy of this prophylactic therapy in transanal endoscopic microsurgery has not been studied yet and is unclear considering the particularities of this procedure. TEM uses a rigid proctoscope of four centimeters of diameter and creates a continuous pneumorectum (insufflation of the rectum during all the procedure). We think that these two elements, which cause local inflammation, may be part of the reason explaining the high incidence of post-operative urinary retention after TEM procedures. The objective of our multicenter clinical trial is to evaluate the effect of perioperative tamsulosin for the reduction of POUR in men, as well as the impact on the interventions and hospital admissions related to this complication.
详细描述
We are conducting a feasibility study (Vanguard phase) with three Canadian centers :
- CHU de Quebec - Laval University, Quebec City, Quebec, Canada
- St-Paul's Hospital, Vancouver, British-Columbia, Canada
- Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
Other Canadian centers will be offered to join our study if the Vanguard phase demonstrates the feasibility of this clinical trial.
Large scale study
We anticipate the detection of a 15% absolute risk reduction of POUR in the Experimental group in comparison with the Placebo group. To detect a 15% reduction of POUR in the Experimental group (10% anticipated) in comparison with the Placebo group (25% anticipated) and to assure a study power of 80% with a unilateral Chi2 and a significance level of 5%, we need 158 patients in total; 79 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
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Everyone is blinded except the pharmacy department where the randomization list is kept. This department is the one able to unblind a patient, if needed.
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 patients of 18 years and older that are scheduled for a TEM resection during the study period.
排除标准
- •Patient already taking an alpha1-adrenergic blocking agent Flomax® (Tamsulosin), Cardura® (Doxazosin), Hytrin® (Terazosine) Rapaflo® (Silodosin), Xatral® (Alfuzosin), Minipress® (Prazosin)
- •Patient having an indwelling bladder catheter
- •Allergy or hypersensibility to any alpha1-adrenergic blocking agent
- •Patient taking one of the following:
- •Anti-retroviral therapy, Antifungal drug, Clarithromycin, Erythromycin, Paroxetine, Terbinafine, Cimetidine, Warfarin, Sildenafil, Tadalafil, Vardenafil (these drugs have possible interactions with the study drug)
研究组 & 干预措施
Placebo
The patients in the Placebo group will receive a placebo oral capsule (sugar) once a day for 5 days before the surgery, one capsule on the day of the surgery and one on the day after. The intervention will consist of a total of 7 capsules
干预措施: Foley catheter (Device)
Placebo
The patients in the Placebo group will receive a placebo oral capsule (sugar) once a day for 5 days before the surgery, one capsule on the day of the surgery and one on the day after. The intervention will consist of a total of 7 capsules
干预措施: Placebo oral capsule (Drug)
Tamsulosin
The patients in the Experimental group will receive Tamsulosin Hydrochloride 0.4 MG (milligrams) once a day for 5 days before the surgery, one capsule on the day of the surgery and one on the day after. The intervention will consist of a total of 7 capsules
干预措施: Tamsulosin Hydrochloride 0.4 MG (Drug)
Tamsulosin
The patients in the Experimental group will receive Tamsulosin Hydrochloride 0.4 MG (milligrams) once a day for 5 days before the surgery, one capsule on the day of the surgery and one on the day after. The intervention will consist of a total of 7 capsules
干预措施: Foley catheter (Device)
结局指标
主要结局
Post-Operative Urinary Retention (POUR) (yes or no)
时间窗: 6 hours
The absence of natural voiding after a surgery needing an intervention as a Foley catheter or a catheterization. If the patient needs this intervention, he will be stated to have had a POUR.
次要结局
- Late POUR(Between 6 hours and 24 hours post-op)
- Indwelling catheter(1 month)
- The International Prostate Symptom Score (IPSS) Score(7 days)
- Side effects of Tamsulosin Hydrochloride(7 days)
- Recurrence(24 hours after the removal of the catheter)
- Hospital admission(24 hours)