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Use of Tamsulosin to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery

NCT01568918 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-05-30

Study results available
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Summary

Postoperative urinary retention is a frequent complication of spinal surgeries and impacts a large portion of this population which results in increased morbidity as a result of increased number of catheterizations, urinary tract infections (UTIs) and prolonged hospital stays. With the addition of Tamsulosin, the investigators would anticipate a reduction in the incidence and duration of postoperative urinary retention and therefore a reduction in morbidity related to treatment of urinary retention as well as shortened hospital stays.

Conditions

  • Postoperative Urinary Retention

Interventions

DRUG

Tamsulosin hydrochloride

Participants will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge.

OTHER

Placebo

The placebo capsule matching the active study drug will be given daily from 5 days prior to the operation until hospital discharge.

Sponsors & Collaborators

Principal Investigators

  • Michelle Clarke, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2019-11-21
Completion
2019-11-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01568918 on ClinicalTrials.gov