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

Last updated: May 2, 2024
Sponsor: Mayo Clinic
Overall Status: Terminated

Phase

3

Condition

Genitourinary Prolapse

Urinary Incontinence

Enuresis

Treatment

Tamsulosin hydrochloride

Placebo

Clinical Study ID

NCT01568918
11-006704
  • Ages > 35
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: Tamsulosin hydrochloride
Phase: 3
Study Start date:
May 01, 2012
Estimated Completion Date:
November 21, 2019

Study Description

Decompressive laminectomy and spinal fusion procedures are among the most common neurosurgical procedures performed. Postoperative urinary retention (POUR) is a frequent complication of such surgeries and impacts a large proportion of this population resulting in multiple intermittent bladder catheterizations for bladder decompression, increased incidence of bacteremia, increased incidence of UTIs, and prolonged hospital stays. Use of a uroselective alpha-1-adrenergic receptor antagonist, such as tamsulosin, in the perioperative period (medication started five days prior to surgery and taken until hospital discharge) could reduce both the incidence and duration of postoperative urinary retention, resulting in shorter hospital stays and decreased healthcare costs.

Connect with a study center

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

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