Use of Tamsulosin to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery
Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Urinary Retention
Intervention: Tamsulosin hydrochloride (Drug); Placebo (Other)
Phase: Phase 3
Status: Recruiting
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s): Michelle Clarke, MD, Principal Investigator, Affiliation: Mayo Clinic
Overall contact: Steven D Thalacker, RN, Phone: 507-255-7906, Email: thals@mayo.edu
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.
Clinical Details
Official title: The Use of an Uroselective Alpha-1-antagonist to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary outcome: Incidence of postoperative urinary retention
Secondary outcome: Duration of postoperative urinary retention
Detailed 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.
Eligibility
Minimum age: 35 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Steven D Thalacker, RN, Phone: 507-255-7906, Email: thals@mayo.edu
Mayo Clinic in Rochester, Rochester, Minnesota 55905, United States; Recruiting Steve Thalacker, RN, Phone: 507-255-7906, Email: thals@mayo.edu Sandra Twaites, Phone: 507-284-5775, Email: twaites.sandra@mayo.edu
Additional Information
Mayo Clinic Clinical Trials
Starting date: May 2012
Last updated: August 13, 2015
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