Prophylactic Tamsulosin Use for Prevention of Post-Operative Urinary Retention

NCT ID: NCT02684344

Last Updated: 2019-01-23

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Post-Operative Urinary Retention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Tamsulosin Group

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

Group Type EXPERIMENTAL

Tamsulosin

Intervention Type DRUG

Tamsulosin may have prophylactic properties against post-operative urinary retention

Education

Intervention Type OTHER

Education about signs and symptoms of urinary retention

Education Group

Subjects will receive:

1\) education about signs and symptoms of urinary retention

Group Type ACTIVE_COMPARATOR

Education

Intervention Type OTHER

Education about signs and symptoms of urinary retention

Interventions

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Tamsulosin

Tamsulosin may have prophylactic properties against post-operative urinary retention

Intervention Type DRUG

Education

Education about signs and symptoms of urinary retention

Intervention Type OTHER

Other Intervention Names

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Flomax

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Edward Messing

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Edward E. Messing, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

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University of Rochester

Rochester, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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59730

Identifier Type: -

Identifier Source: org_study_id

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