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Post-operative Urinary Retention (POUR) Following Thoracic Surgery

Post-operative Urinary Retention (POUR) Following Thoracic Surgery

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03609580
Acronym
POUR
Enrollment
127
Registered
2018-08-01
Start date
2018-05-07
Completion date
2027-03-30
Last updated
2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Retention

Keywords

post operative urinary retention, inability to urinate, urinary retentions, lung cancer, VATs, Robotic Lung Surgery, lung resections

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.

Interventions

DRUGTamsulosin - 1 week

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.

DRUGTamsulosin - 3 days

The investigators hypothesize that pre-operative administration of Tamusolin (Flomax, 0.4mg/day x 3 days), 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.

Sponsors

Hackensack Meridian Health
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Volume of urine (cc) post thoracic surgery in patients that received Flomax, 0.4mg/day for a week before surgery8 hoursThe absence of voiding naturally after undergoing thoracic surgery needing an intervention as a Foley catheter or a catheterization. Documentation for first void, Post bladder scan showing more that 300cc of residual urine in the bladder (failure to urinate), or following spontaneous urination if there is more than 300cc of residual urine in the bladder (inadequate urination)

Countries

United States

Contacts

CONTACTMichael Spallone, MD
michael.spallone@hmhn.org551-996-2000
PRINCIPAL_INVESTIGATORMichael Spallone, MD

Hackensack Meridian Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026