RecruitingEarly Phase 1NCT05657990

Post Operative Urinary Retention (POUR) Following Thoracic Oncological Surgery

Sponsor

Hackensack Meridian Health

Enrollment

46 participants

Start Date

Apr 3, 2023

Study Type

INTERVENTIONAL

Conditions

Urinary Retention

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.

Eligibility

Sex: MALEMin Age: 55 Years

Inclusion Criteria4

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 Criteria8

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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Interventions

DRUGTamsulosin

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.