What this study is
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.
What's being tested
- Tamsulosin
Intervention · 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
- Sponsor
- Hackensack Meridian Health
- Conditions
- Urinary Retention
- Enrolling
- 46 people
- Starts
- 2023-04-03
- Est. completion
- 2027-06
- Design
- Open-label, single group, Early Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 55 Years and overSex MALEHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (4)
4 openContact for every open site
- Denise Theiler · Contact732-776-3301Denise.Theiler@hmhn.org
Contact for 3 of 4 open sites
- Thomas Bauer, MD · Principal investigator
Ocean University Medical Center
Brick, New Jersey, United States
RecruitingSouth Ocean University Medical Center
Manahawkin, New Jersey, United States
RecruitingJersey Shore University Medical Center
Neptune City, New Jersey, United States
RecruitingRiverview Medical Center
Red Bank, New Jersey, United States
- Ziad Hanhan, MD · Sub-investigator
Recruiting
Study team
Sponsor
Hackensack Meridian Health
Study ID Pro2022-0489
Principal investigator
Thomas Bauer, MD
Hackensack Meridian Health
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.