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

University of Massachusetts, Worcester

Status and phase: Terminated; Phase 4

Conditions: Urinary Retention; Thoracic Diseases

Treatments: Drug: Tamsulosin Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT04994431

H00018178

Details and patient eligibility

About

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.

Full description

Post-operative urinary retention (POUR) is one of the most common post-operative complications encountered by most surgical specialties. The incidence of POUR can vary from five to 70%.

Post-operative urinary retention is a prevalent complication. Patients who undergo thoracic surgery have greater urinary retention rates compared to others. Data on effective methods to reduce the risk of POUR in this high-risk group are limited.

All subjects who meet inclusion and exclusion criteria will be invited to participate. There will be no randomization. All will receive tamsulosin in the pre operative period.

Enrollment: 109 patients

Sex: Male

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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109 participants in 2 patient groups

Perioperative Tamsulosin Hydrochloride

Experimental group

Description:

Participants undergoing thoracic surgery will receive 0.4mgTamsulosin Hydrochloride orally nightly for the two nights immediately prior to surgery and the morning of surgery.

Treatment:

Drug: Tamsulosin Hydrochloride

Historical Comparator

No Intervention group

Description:

Participants who underwent thoracic surgery (historical). Information about occurrence of Peri-Operative Urinary Retention in thoracic surgery patients will be obtained via retrospective chart review.