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Post Operative Urinary Retention (POUR) Following Thoracic Oncological Surgery

Primary Purpose

Urinary Retention

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tamsulosin
Sponsored by
Hackensack Meridian Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Retention focused on measuring Urinary Retention, post surgery Urinary Retention, thoracic surgery, spontaneous voiding, bladder retention, Tamsulosin (FlomaxTM), kidney injury, men undergoing thoracic oncological surgical procedure, BladderScanner

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Ocean University Medical Center
  • South Ocean University Medical Center
  • Jersey Shore University Medical CenterRecruiting
  • Riverview Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pre-operative Tamsulosin administration

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of participants that were able to spontaneously void after surgery completion
Self-reported void within 6-8 hours post operative
Time of the void
Time (number of minutes) to first postoperative spontaneous urination post operation
Volume of urine
Volume of urine during the first postoperative spontaneous urination post operation.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 12, 2022
Last Updated
April 4, 2023
Sponsor
Hackensack Meridian Health
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1. Study Identification

Unique Protocol Identification Number
NCT05657990
Brief Title
Post Operative Urinary Retention (POUR) Following Thoracic Oncological Surgery
Official Title
Post Operative Urinary Retention (POUR) Following Thoracic Oncological Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 3, 2023 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hackensack Meridian Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention
Keywords
Urinary Retention, post surgery Urinary Retention, thoracic surgery, spontaneous voiding, bladder retention, Tamsulosin (FlomaxTM), kidney injury, men undergoing thoracic oncological surgical procedure, BladderScanner

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pre-operative Tamsulosin administration
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Other Intervention Name(s)
Flomax
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants that were able to spontaneously void after surgery completion
Description
Self-reported void within 6-8 hours post operative
Time Frame
6-8 hours post operative
Title
Time of the void
Description
Time (number of minutes) to first postoperative spontaneous urination post operation
Time Frame
Within 24 hours post operative
Title
Volume of urine
Description
Volume of urine during the first postoperative spontaneous urination post operation.
Time Frame
Within 24 hours post operative
Title
Amount of residual urine
Description
Patients will receive a bladder scan post their first postoperative spontaneous urination and the amount of residual urine will be measured.
Time Frame
Within 24 hours post operative
Title
Number of participants that needed an intervention due to failure to spontaneously urinate
Description
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.
Time Frame
Within 24 hours post operative

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Denise Theiler, RN
Phone
7327763301
Email
Denise.Theiler@hmhn.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Bauer, MD
Organizational Affiliation
Hackensack Meridian Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ocean University Medical Center
City
Brick
State/Province
New Jersey
ZIP/Postal Code
08724
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Theiler
Phone
732-776-3301
Email
Denise.Theiler@hmhn.org
First Name & Middle Initial & Last Name & Degree
Dennis Vega, MD
Facility Name
South Ocean University Medical Center
City
Manahawkin
State/Province
New Jersey
ZIP/Postal Code
08050
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Theiler
Phone
732-776-3301
Email
Denise.Theiler@hmhn.org
First Name & Middle Initial & Last Name & Degree
Dennis Vega, MD
Facility Name
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Theiler, RN
Phone
732-776-3301
Email
Denise.Theiler@hmhn.org
First Name & Middle Initial & Last Name & Degree
Thomas Bauer, MD
Facility Name
Riverview Medical Center
City
Red Bank
State/Province
New Jersey
ZIP/Postal Code
07701
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Theiler
Phone
732-776-3301
Email
Denise.Theiler@hmhn.org
First Name & Middle Initial & Last Name & Degree
Ziad Hanhan, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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
Results Reference
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Post Operative Urinary Retention (POUR) Following Thoracic Oncological Surgery

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