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

  • STATUS
    Recruiting
  • End date
    Dec 10, 2023
  • participants needed
    350
  • sponsor
    Mayo Clinic
Updated on 10 March 2022

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.

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.

Details
Condition Postoperative Urinary Retention
Treatment Placebo, Tamsulosin Hydrochloride
Clinical Study IdentifierNCT01568918
SponsorMayo Clinic
Last Modified on10 March 2022

Eligibility

Yes No Not Sure

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
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