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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

Page last updated: August 20, 2015

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