Post Operative Urinary Retention (POUR) Following Thoracic Oncological Surgery

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Tamsulosin
  Tamsulosin 0.4 mg one time daily after a meal for seven days prior to surgery. Post-surgery, an ultrasound of the bladder will be completed approximately six hours after surgery to assess the bladder. If the bladder ultrasound shows more than 400 cc of urine in the bladder, or if the study subject passes urine on his own and there is more than 100cc or less than 400 cc of urine left in the bladder, he will be encouraged to try to pass urine. Study subject will be monitored for two additional hou

Первичные конечные точки

• Number of participants that were able to spontaneously void after surgery completion [Срок оценки: 6-8 hours post operative]
• Time of the void [Срок оценки: Within 24 hours post operative]
• Volume of urine [Срок оценки: Within 24 hours post operative]
• Amount of residual urine [Срок оценки: Within 24 hours post operative]
• Number of participants that needed an intervention due to failure to spontaneously urinate [Срок оценки: Within 24 hours post operative]

Критерии участия

Критерии включения

• Males
• ≥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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 4 центра

• Ocean University Medical Center — Brick
• South Ocean University Medical Center — Manahawkin
• Jersey Shore University Medical Center — Neptune City
• Riverview Medical Center — Red Bank

Публикации

• 1. Agrawal K, Majhi S, Garg R. Post-operative urinary retention: Review of literature. World J Anesthesiol 2019; 8(1): 1-12 [DOI: 10.5313/wja.v8.i1.1] 2. Akkoc A, Aydin C, Topaktas R, Kartalmis M, Altin S, Isen K, Metin A. Prophylactic effects of alpha-blockers, Tamsulosin and Alfuzosin, on postoperative urinary retention in male patients undergoing urologic surgery under spinal anaesthesia. Int B
• 6. Hollingsworth JM, Rogers MA, Krein SL, et al. Determining the Noninfectious Complications of Indwelling Urethral Catheters. A Systemic Review and Meta-Analysis. Ann Intern Med 2013: 159; 401-410. 7. Jackson J, Davies P, Leggett N, Nugawela MD, Scott LJ, Leach V, Richards A, Blacker A, Abrams P, Sharma J, Donovan J, Whiting P. Systematic review of interventions for the prevention and treatment o
• 11. Patel JA, Kaufman AS, Howard RS, et al. Risk Factors for Urinary Retention after Laparoscopic Inguinal Hernia Repairs. Surg Endosc 2015: 29; 3140-3145. 12. R Core Team (2020). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. URL https://www.R-project.org/. 13. Simon R. (1989). Optimal Two-Stage Designs for Phase II Clinical Trial

Идентификаторы

NCT: NCT05657990 · Pro2022-0489

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗