Prophylactic Tamsulosin Use for Prevention of Post-Operative Urinary Retention

University of Rochester

Status: Terminated

Conditions: Post-Operative Urinary Retention

Treatments: Drug: Tamsulosin; Other: Education

Study type: Interventional

Funder types: Other

Identifiers

NCT02684344

59730

Details and patient eligibility

About

This randomized open-label study will be comprised of 2 cohorts: one control group and one treatment group. The trial will be conducted as an open label randomized trial to evaluate the efficacy of tamsulosin in the prevention of post-operative urinary retention. The study will include pre- and post-surgical evaluations of patients including symptoms of urinary retention and any adverse effects contributable to the study medication.

Enrollment: 5 patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any male age 40 or older
• Scheduled to undergo one of the planned surgeries (thoracic, general, or urologic)
• Ability to give informed consent

Exclusion criteria

• Current use of alpha blocker
• Current use of a strong CYP 3A4 inhibitors
• Any allergy to tamsulosin, alpha-blocker medication class, or anaphylaxis allergy to sulfate containing medications
• Patients with any upcoming surgery for cataracts
• Currently enrolled in a clinical trial
• Inability to give informed consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Tamsulosin Group

Experimental group

Description:

Subjects will receive: 0.4mg tamsulosin by mouth nightly for 3 doses prior to the day of surgery and for 2 doses following surgery education about signs and symptoms of urinary retention

Treatment:

Other: Education

Drug: Tamsulosin

Education Group

Active Comparator group

Description:

Subjects will receive: 1) education about signs and symptoms of urinary retention

Treatment:

Other: Education