Post Operative Urinary Retention (POUR) Following Thoracic Oncological Surgery
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 7
- 主要终点
- Time of the void
研究概览
简要总结
This is a feasibility study looking at whether the use of Tamsulosin could lower the high incidence of postoperative urinary retention (POUR) in older men who undergo an oncological thoracic surgical procedure for suspected or confirmed cancer. In addition, the study will try to identify the time of resumption of presurgical urinary function post Tamsulosin administration.
详细描述
Post-operative urinary retention (POUR) is a significant problem in post-operative patients. The incidence varies, but can reach up to 70%, which most commonly affects older men with enlarged prostates. Even after adjusting for the modifiable risk factors, such as decreased intraoperative foley use and post-operative narcotic use, the incidence remains high. This causes an increase in urinary tract infections, patient discomfort, longer hospital stays, and occasionally further urologic complications. Studies have shown that the use of tamsulosin, an alpha1-adrenergic receptor blocker, may decrease the incidence of POUR by improving urinary flow via relaxation of the smooth muscle tissue. Therefore, the goal of our study is to investigate whether Tamsulosin (Flomax) can be used to lower incidence of POUR in older men undergoing an oncological thoracic surgical procedure.
This is a pilot/feasibility/ early efficacy study to determine if treating men > 55 years of age with Tamsulosin prior to a thoracic oncological surgery will prevent postoperative urinary retention (POUR).
Subjects will be provided with a prescription for Tamsulosin (generic) to be taken 7 days prior to scheduled surgery. For research purposes, post-surgical spontaneous voids will be measured, and any residual urine in the bladder will be assessed and measured using a BladderScanner. This data will be used to determine postoperative urinary retention (POUR). Additionally, standard of care bladder management will be used if the subject did not spontaneously void or had excess urine residual. The algorithm in the table below will guide bladder management decisions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •≥55 years old
- •Planned thoracic oncological surgical procedure of a video assisted oncological surgical procedure for suspected or confirmed cancer.
- •Surgery scheduled more than 7 days from the time of consent
排除标准
- •Using Tamsulosin already
- •Known allergy to Tamsulosin or sulfa drugs
- •Current use of Boceprevir
- •Resting systolic blood pressure <100
- •Orthostatic hypotension of >20mm Hg systolic and/or 10mm Hg diastolic pressure from sitting to standing (after 2 minutes of standing) as measured at the time of consent
- •Known history of hypotension
- •Known diagnosis of congestive heart failure (CHF) and valvular heart disease
- •History of prior prostate surgery (prostatectomy, trans-urethral resection)
研究组 & 干预措施
Pre-operative Tamsulosin administration
Subjects will be provided with a prescription for Tamsulosin (generic) to be taken 7 days prior to scheduled surgery for thoracic cancer. Tamsulosin dose is set at 0.4mg/day and should be taken daily for seven days prior to their planned surgery date. Study subjects will also be given a diary to record their daily usage. Study subjects should take Tamsulosin on the day of the surgery with a sip of water.
干预措施: Tamsulosin (Drug)
结局指标
主要结局
Time of the void
时间窗: Within 24 hours post operative
Time (number of minutes) to first postoperative spontaneous urination post operation
Number of participants that were able to spontaneously void after surgery completion
时间窗: 6-8 hours post operative
Self-reported void within 6-8 hours post operative
Volume of urine
时间窗: Within 24 hours post operative
Volume of urine during the first postoperative spontaneous urination post operation.
Amount of residual urine
时间窗: Within 24 hours post operative
Patients will receive a bladder scan post their first postoperative spontaneous urination and the amount of residual urine will be measured.
Number of participants that needed an intervention due to failure to spontaneously urinate
时间窗: Within 24 hours post operative
Patients that did not spontaneously urinate within 6-8 hours post operative will have an intervention. Potential interventions include : a) Prompted voiding and rescanning in 2 hours; b) Intermittent catheterization and patient prompting; c) Indwelling catheter inserted.
次要结局
未报告次要终点