Recruiting
Early Phase 1

Observational Study

Sponsor:

Hackensack Meridian Health

Code:

NCT05657990

Conditions

Urinary Retention

Eligibility Criteria

Sex: Male

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Tamsulosin

Study Details

Brief 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.

Conditions

Urinary Retention

Study ID

NCT05657990

Start date

Apr 3, 2023

Status verified date

Sep, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 55+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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)

Study Design

Enrollment

46 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Tamsulosin

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.

Primary outcome measure

  • Number of participants that were able to spontaneously void after surgery completion [ Time Frame: 6-8 hours post operative ]
  • Time of the void [ Time Frame: Within 24 hours post operative ]
  • Volume of urine [ Time Frame: Within 24 hours post operative ]
  • Amount of residual urine [ Time Frame: Within 24 hours post operative ]
  • Number of participants that needed an intervention due to failure to spontaneously urinate [ Time Frame: Within 24 hours post operative ]

Central Contacts and Locations

Central contacts

Denise Theiler, RN

7327763301Denise.Theiler@hmhn.org

Locations

Ocean University Medical Center

Recruiting

Brick, New Jersey, United States, 08724

Contacts

Denise Theiler

732-776-3301Denise.Theiler@hmhn.org

Principal Investigator:

Thomas Bauer, MD

South Ocean University Medical Center

Recruiting

Manahawkin, New Jersey, United States, 08050

Contacts

Denise Theiler

732-776-3301Denise.Theiler@hmhn.org

Principal Investigator:

Thomas Bauer, MD

Jersey Shore University Medical Center

Recruiting

Neptune City, New Jersey, United States, 07753

Contacts

Denise Theiler, RN

732-776-3301Denise.Theiler@hmhn.org

Principal Investigator:

Thomas Bauer, MD

Riverview Medical Center

Recruiting

Red Bank, New Jersey, United States, 07701

Contacts

Denise Theiler

732-776-3301Denise.Theiler@hmhn.org

More Information

Sponsor

Hackensack Meridian Health

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

  • Urinary Retention
  • post surgery Urinary Retention
  • thoracic surgery
  • spontaneous voiding
  • bladder retention
  • Tamsulosin (FlomaxTM)
  • kidney injury
  • men undergoing thoracic oncological surgical procedure
  • BladderScanner

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hackensack Meridian Health on 2026-09-09.