Post Operative Urinary Retention (POUR) Following Thoracic Oncological Surgery

Early Phase 1RecruitingNCT05657990

Hackensack Meridian Health46 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Urinary Retention

Interventions

TamsulosinDRUG

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.

Eligibility

Sex: MALEMin age: 55 Years

Medical Language ↔ Plain English

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)

Locations (4)

Ocean University Medical Center

Brick, New Jersey, United States

RECRUITING

South Ocean University Medical Center

Manahawkin, New Jersey, United States

RECRUITING

Jersey Shore University Medical Center

Neptune City, New Jersey, United States

Outcomes

Primary Outcomes

Number of participants that were able to spontaneously void after surgery completion

Self-reported void within 6-8 hours post operative

Time frame: 6-8 hours post operative

Time of the void

Time (number of minutes) to first postoperative spontaneous urination post operation

Time frame: Within 24 hours post operative

Volume of urine

Volume of urine during the first postoperative spontaneous urination post operation.

Time frame: Within 24 hours post operative

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.

Time frame: Within 24 hours post operative

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.

Time frame: Within 24 hours post operative

Central Contacts

Denise Theiler, RN

CONTACT

7327763301 Denise.Theiler@hmhn.org

Data from ClinicalTrials.gov

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