Post Operative Urinary Retention (POUR) Following Thoracic Oncological Surgery

Early Phase 1

Recruiting

• Conditions: Urinary Retention
• Interventions: Drug: Tamsulosin

• Registration Number: NCT05657990
• Lead Sponsor: Hackensack Meridian Health

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.

Study Timeline

• Study First Submitted: 2022-12-12
• Study First Submitted QC: 2022-12-12
• Study First Posted: 2022-12-20
• Study Start: 2023-04-03
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-31
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 46

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pre-operative Tamsulosin administration	Tamsulosin	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.

Primary Outcome Measures

Name	Time	Method
Time of the void	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	6-8 hours post operative	Self-reported void within 6-8 hours post operative
Volume of urine	Within 24 hours post operative	Volume of urine during the first postoperative spontaneous urination post operation.
Amount of residual urine	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	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.

Trial Locations

Locations (4)

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, United States