Post Operative Urinary Retention (POUR) Following Thoracic Oncological Surgery

Part of paid clinical trials in Brick, New Jersey.

Sponsor
Hackensack Meridian Health
Study ID
NCT05657990
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Urinary Retention

Eligibility Criteria

Sex
MALE
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tamsulosin — DRUG
    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.

Study Details

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.

Key Dates

Start date
Apr 3, 2023
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
46 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Pre-operative Tamsulosin administration
    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 Measure

Number of participants that were able to spontaneously void after surgery completion [ Time Frame: 6-8 hours post operative ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Ocean University Medical CenterBrickNew Jersey08724
Denise Theiler
[email protected]
732-776-3301
Thomas Bauer, MD (PRINCIPAL_INVESTIGATOR)
South Ocean University Medical CenterManahawkinNew Jersey08050
Denise Theiler
[email protected]
732-776-3301
Thomas Bauer, MD (PRINCIPAL_INVESTIGATOR)
Jersey Shore University Medical CenterNeptune CityNew Jersey07753
Denise Theiler, RN
[email protected]
732-776-3301
Thomas Bauer, MD (PRINCIPAL_INVESTIGATOR)
Riverview Medical CenterRed BankNew Jersey07701
Denise Theiler
[email protected]
732-776-3301
Ziad Hanhan, MD (SUB_INVESTIGATOR)

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Ocean University Medical Center· Brick, NJSouth Ocean University Medical Center· Manahawkin, NJJersey Shore University Medical Center· Neptune City, NJRiverview Medical Center· Red Bank, NJ

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