Clinical trial

Post-Operative Urinary Retention (POUR) in Thoracic Surgery Patients Receiving Prophylactic Tamsulosin

Name

H00018178

Description

Post-Operative Urinary Retention (POUR) in Thoracic Surgery is a prospective interventional study aiming to test the hypothesis that the prophylactic use of tamsulosin prior to thoracic surgery in high risk patients leads to reduce the rates of POUR.

Trial arms

Trial start

2021-08-01

Estimated PCD

2025-06-30

Trial end

2025-12-31

Status

Recruiting

Phase

Early phase I

Treatment

Tamsulosin Hydrochloride

0.4mg orally nightly for the two days immediately prior to surgery and the morning of surgery.

Arms:

Perioperative Tamsulosin Hydrochloride

Size

Primary endpoint

Participants with Post-Operative Urinary Retention (Pour)

5 days

Eligibility criteria

Inclusion Criteria: * All male patients \>=60 years old who undergo inpatient thoracic surgery for major resections. Exclusion Criteria: * - Prisoners * Adults unable to consent * End stage renal disease on hemodialysis * Indwelling urinary catheter * Child-Pugh class C hepatic failure * Usage of the following medications prior to surgery: strong CYP 3A4 inhibitors, strong CYP2D6 inhibitors, other alpha-adrenergic blocking agents, PDE5 inhibitors, and cimetidine * patients known to be CYP2D6 poor metabolizers * History of prostatectomy or cystectomy * Patients with contraindications to tamsulosin and those at high risk for side effects: hypersensitivity to tamsulosin HCl or any component of FLOMAX capsules, hypersensitivity to sulfonamides. History of known glaucoma, hypotension, plan to undergo cataract surgery in the next 2 weeks

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All subjects that sign a study consent and meet inclusion and exclusion criteria will receive the the study drug.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2023-05-25

1 organization

1 product

2 indications

Organization

Product

Indication

Indication