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

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 11-006704
    NCT ID: NCT01568918
    Sponsor Protocol Number: 11-006704

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • ≥ 35 years (Males & Females)
  • Cervical Laminectomy
  • Cervical Posterior Fusion
  • Cervical Anterior/Posterior Fusion
  • Lumbar Laminectomy
  • Lumbar Posterolateral Fusion
  • Lumbar Interbody Fusion

Exclusion Criteria

  • < 35 years
  • Cervical Anterior Discectomy and Fusion
  • Cervical Anterior Corpectomy
  • Cervical Posterior Discectomy
  • Cervical Foraminotomy
  • Lumbar Discectomy (METRx or Open)
  • Lumbar Foraminotomy
  • Lumbar Anterior Fusion
  • Myelopathy with bladder dysfunction
  • Patients currently taking an alpha-antagonist
  • Patients with history of allergy or sensitivity to tamsulosin or other alpha-antagonist (alfuzosin, doxazosin, prazosin, terazosin, tamsulosin, and phenoxybenzamine)
  • History of prostatectomy or urologic surgery involving the bladder or urethra
  • Severe liver disease or end-stage renal disease
  • Patients taking strong inhibitors of CYP3A4 (ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir/ritonavir, lopinavir/ritonavir, and conivaptan)
  • Patients with a mental disability
  • Prisoners

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Michelle Clarke, M.D.

Open for enrollment

Contact information:

Steven Thalacker R.N.

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20112059

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