Prophylactic Tamsulosin Use for Prevention of Post-Operative Urinary Retention

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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)

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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