Post Operative Urinary Retention (POUR) Following Thoracic Oncological Surgery

Urinary Retention Clinical Trial

Official title:

Post Operative Urinary Retention (POUR) Following Thoracic Oncological Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05657990
• Other study ID #: Pro2022-0489
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 3, 2023
• Est. completion date: December 2026

Study information

• Verified date: January 2024
• Source: Hackensack Meridian Health
• Contact: Denise Theiler, RN
• Phone: 7327763301
• Email: Denise.Theiler[@]hmhn.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Urinary Retention

Intervention

Drug:
• 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 hours. If a study subject is unable to pass urine at this time or the bladder has 400 cc or more of urine left in it, he will have an intermittent catheter (in and out) to drain urine. If the bladder has greater than 500 cc (which is approximately 16 and two-thirds ounces) per catheterization for more than 24 hours, and the study subject cannot pass urine, an indwelling catheter may be considered.

Locations

Country	Name	City	State
United States	Ocean University Medical Center	Brick	New Jersey
United States	South Ocean University Medical Center	Manahawkin	New Jersey
United States	Jersey Shore University Medical Center	Neptune	New Jersey
United States	Riverview Medical Center	Red Bank	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Hackensack Meridian Health

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 Braz J Urol. 2016 May-Jun;42(3):578-84. doi: 10.1590/S1677-5538.IBJU.2015.0256. PMID: 27286124; PMCID: PMC4920578. 3. Baldani G, Bagry H, Aprikian A, et al. Post-Operative Urinary Retention. Anesthesiology 2009; 110 (5): 1139-1157. 4. Benjamin Wei, Ammar Asban, Rongbing Xie, Zachary Sollie, Luqin Deng, Thomas K. DeLay, William B. Swicord, Rajat Kumar, James K. Kirklin, James Donahue. A prediction model for postoperative urinary retention after thoracic surgery. JTCVS Open. Volume 7. 2021. Pages 359-366. ISSN 2666-2736. https://doi.org/10.1016/j.xjon.2021.05.006. 5. Fisher E, Subramonian K, Omar MI. The role of alpha blockers prior to removal of urethral catheter for acute urinary retention in men. Cochrane Database Syst Rev. 2014 Jun 10;(6):CD006744. doi: 10.1002/14651858.CD006744.pub3. PMID: 24913721.

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 Trials. Controlled Clinical Trials 10, 1-10. 14. Sivasankaran MV, Pham T, Divino CM. Incidence and Risk Factors for Urinary Retention Following Laparoscopic Inguinal Hernia Repair. Am J Surg 2014; 207: 288-292. 15. "Tamsulosin hydrochloride-Drug Summary." PDR Prescribers' Digital Reference (2021). Retrieved from https://www.pdr.net/drug-summary/Flomax-tamsulosin-hydrochloride-2893.5649 16. Venkatraman E. Seshan (2018). clinfun: Clinical Trial Design and Data Analysis Functions. R package version 1.0.15. Retrieved from https://CRAN.R-project.org/package=clinfun

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 of postoperative urinary retention. BJS Open. 2018 Nov 19;3(1):11-23. doi: 10.1002/bjs5.50114. PMID: 30734011; PMCID: PMC6354194. 8. Kun Woo Kim, Jae-Ik Lee, Ji Sung Kim, Young-Jin Lee, Won-Jun Choi, Han Jung, Kook-Yang Park, Chul-Hyun Park, Kuk-Hui Son, Risk factors for urinary retention following minor thoracic surgery, Interactive CardioVascular and Thoracic Surgery, Volume 20, Issue 4, April 2015, Pages 486-492, https://doi.org/10.1093/icvts/ivu445 9. Lepor H, Tamsulosin Investigator Group. Phase III Multicenter Placebo-Controlled Study of Tamsulosin in Benign Prostatic Hyperplasia. Urology 1998: 51; 892-900. 10. Madani AH, Aval HB, Mokhtari G, et al. Effectiveness of Tamsulosin in Prevention of Post-Operative Urinary Retention: A Randomized Double-Blind Placebo-Controlled Trial. Braz J of Urol 2014; 40(1): 30-36.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants that were able to spontaneously void after surgery completion	Self-reported void within 6-8 hours post operative	6-8 hours post operative
Primary	Time of the void	Time (number of minutes) to first postoperative spontaneous urination post operation	Within 24 hours post operative
Primary	Volume of urine	Volume of urine during the first postoperative spontaneous urination post operation.	Within 24 hours post operative
Primary	Amount of residual urine	Patients will receive a bladder scan post their first postoperative spontaneous urination and the amount of residual urine will be measured.	Within 24 hours post operative
Primary	Number of participants that needed an intervention due to failure to spontaneously urinate	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.	Within 24 hours post operative