The Use of an Uroselective Alpha-1-antagonist to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of incidences of POUR (Postoperative urinary retention)
研究概览
简要总结
The purpose of this research is to see if the use of tamsulosin can decrease both the incidence and duration of urinary retention, as well as hospital length of stay following spine surgery.
详细描述
Postoperative urinary retention is a frequent complication of spinal surgeries and impacts a large portion of this population which results in increased morbidity as a result of increased number of catheterizations, urinary tract infections and prolonged hospital stays. With the addition of Tamsulosin, we would anticipate a reduction in the incidence and duration of postoperative urinary retention and therefore a reduction in morbidity related to treatment of urinary retention as well as shortened hospital stays.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cervical Laminectomy
- •Cervical Posterior Fusion
- •Cervical Anterior/Posterior Fusion
- •Lumbar Laminectomy
- •Lumbar Posterolateral Fusion
- •Lumbar Interbody Fusion
排除标准
- •Cervical Anterior Discectomy and Fusion
- •Cervical Anterior Corpectomy
- •Cervical Posterior Discectomy
- •Cervical Foraminotomy
- •Lumbar Discectomy (METRx or Open)
- •Lumbar Foraminotomy
- •Lumbar Anterior Fusion
- •Myelopathy with bladder dysfunction
- •Patients currently taking an alpha-antagonist
- •o The following drugs are alpha antagonists: alfuzosin, doxazosin, prazosin, terazosin, tamsulosin, and phenoxybenzamine.
- •Patients with history of allergy or sensitivity to tamsulosin or other alpha-antagonist
- •History of prostatectomy or urologic surgery involving the bladder or urethra
- •Severe liver disease or end-stage renal disease
- •Patients taking strong inhibitors of CYP3A4
- •o The following drugs are strong inhibitors of CYP3A4: ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir/ritonavir, lopinavir/ritonavir, and conivaptan.
- •Mental disability or prisoner
- •Pregnancy (for anesthesia purposes)
研究组 & 干预措施
Treatment Group
Neurosurgical patients undergoing decompressive laminectomy and/or spinal fusion who will receive uroselective alpha-1-adrenergic receptor antagonist Tamsulosin
干预措施: Uroselective alpha-1-adrenergic receptor antagonist (Drug)
Control Group
Neurosurgical patients undergoing decompressive laminectomy and/or spinal fusion who will receive a placebo
干预措施: Placebo (Other)
结局指标
主要结局
Number of incidences of POUR (Postoperative urinary retention)
时间窗: Post-operatively through end of hospital stay, approximately 8-12 days
Total number of incidences of POUR (Postoperative urinary retention). POUR is defined as any of the following: estimated post-void residual (PVR) volume of urine greater than or equal to 300 mL; estimated retention urine volume of greater than or equal to 500 mL in patients unable to void; or patients experiencing discomfort or distension and unable to void with lesser residual urine volume than 500 ml.
次要结局
- Duration of POUR (Postoperative urinary retention)(Post-operatively through end of hospital stay, approximately 8-12 days)
- Number of intermittent catheterizations in those with urinary retention(Post-operatively through end of hospital stay, approximately 8-12 days)
- Incidence of UTI (urinary tract infection)(Post-operatively through end of hospital stay, approximately 8-12 days)
- Duration of hospital stay(Post-operatively through end of hospital stay, approximately 8-12 days)
研究者
Michelle J. Clarke
Principal Investigator
Mayo Clinic