Prophylactic Tamsulosin Use for Prevention of Post-Operative Urinary Retention

Post-Operative Urinary Retention Clinical Trial

Official title:

Prophylactic Tamsulosin Use for Prevention of Post-Operative Urinary Retention

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02684344
• Other study ID #: 59730
• Status: Terminated
• Phase: N/A
• Start date: February 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2019
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post-Operative Urinary Retention
• Urinary Retention

Intervention

Drug:
• Tamsulosin
Tamsulosin may have prophylactic properties against post-operative urinary retention

Other:
• Education
Education about signs and symptoms of urinary retention

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Post-operative Urinary Retention		5 days