Prophylactic Tamsulosin Use for Prevention of Post-Operative Urinary Retention

NCT02684344 | Terminated Results DMC FDA Drug

• 1 other identifier: 59730
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-Operative Urinary Retention

Keywords

Post-Operative Urinary Retention

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Post-operative Urinary Retention

  5 days

Study Arms (2)

Tamsulosin Group

EXPERIMENTAL

Subjects will receive: 1. 0.4mg tamsulosin by mouth nightly for 3 doses prior to the day of surgery and for 2 doses following surgery 2. education about signs and symptoms of urinary retention

Drug: Tamsulosin; Other: Education

Education Group

ACTIVE COMPARATOR

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

Other: Education

Interventions

Tamsulosin DRUG

Tamsulosin may have prophylactic properties against post-operative urinary retention

Also known as: Flomax

Tamsulosin Group

Education OTHER

Education about signs and symptoms of urinary retention

Education Group; Tamsulosin Group

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Interventions

Tamsulosin; Educational Status

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Socioeconomic Factors; Population Characteristics

Results Point of Contact

• Title: Edward Messing
• Organization: University of Rochester

edward_messing@urmc.rochester.edu

585 - 275 - 0998

Study Officials

• Edward E. Messing, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 8, 2016
• First Posted: February 18, 2016
• Study Start: February 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 23, 2019
• Results First Posted: January 23, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)