Clinical trial NCT03609580: Post-operative Urinary Retention (POUR) Following Thoracic Surgery
Official title: Post-operative Urinary Retention (POUR) Following Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Urinary Retention
Keywords: post operative urinary retention
inability to urinate
urinary retentions
lung cancer
VATs
Robotic Lung Surgery
lung resections
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 127
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Inability to urinate a common complication that happens to many patients after a surgery, especially in men over 60 years of age who undergo surgery on their chest. Urinary retention is uncomfortable, increases anxiety, increases hospital length of stay, and leads to more procedures such as putting in a bladder catheter (Foley). This is uncomfortable, and can lead to bleeding, infection, damage to the urethra and/or bladder and bladder spasm. The goal of this study is to attempt to prevent inability to urinate by giving patients a medication called Flomax (Tamusolin) every day beginning a week before surgery. That medication relaxes the prostate. It's approved by the Food and Drug Administration (FDA) to improve urinary flow in those with enlarged prostates. It is also commonly used in patients with bladder problems due to inability to urinate who have required a Foley.

Detailed description: Post-operative urinary retention (POUR) in older men who undergo a thoracic surgical procedure occurs in a significant proportion of patients (25% at Hackensack University Medical Center in men \>60) and is a significant management problem. Typically, this complication needs to be treated with placement of a bladder catheter (foley). In addition to the discomfort of placing a foley in an awake patient, these patients are at a significantly increased risk of a catheter associated urinary tract infection (CAUTI), potential genito-urinary injury during the placement, and bladder muscle damage due to distention.

The goal of this study is to investigate whether the use of Tamusolin could lower the high incidence of POUR in older men undergoing a thoracic surgical procedure.

The investigators hypothesize that pre-operative administration of Tamusolin (Flomax, 0.4mg/day x 1 week), with ongoing use post-operatively until normal voiding resumes, will result in a significant decrease in the incidence of POUR after a thoracic surgical procedure.

Eligibility criteria: Inclusion Criteria:

Males

≥50 years old Planned surgical procedure of a minimally invasive thoracic surgical procedure (wedge resection, segmentectomy, lobectomy, pleural biopsy, or pleurodesis) Surgery scheduled more than 3 days from the time of consent

Exclusion Criteria:

* Using Flomax already
* Allergy to Flomax or sulfa drugs
* Current use of alpha blockers or alpha agonists
* Resting systolic blood pressure \<100
* Orthostatic hypotension of \>20mm Hg (millimeters of mercury) Systolic and/or 10mm Hg diastolic pressure from sitting to standing (after 2 minutes of standing) as measured at the time of consent
* Known diagnosis of congestive heart failure and valvular heart disease
* History of prostate surgery (prostatectomy, trans-urethral resection)

Primary outcomes:
measure: Volume of urine (cc) post thoracic surgery in patients that received Flomax, 0.4mg/day for a week before surgery
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Daniel Mansour
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health
name: Daniel Mansour, MD
role: PRINCIPAL_INVESTIGATOR
References: