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Purpose

The purpose of this research is to see if the use of tamsulosin can decrease both the incidence and duration of urinary retention, as well as hospital length of stay following spine surgery.

Condition

Eligibility

Eligible Ages
Over 35 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Cervical Laminectomy - Cervical Posterior Fusion - Cervical Anterior/Posterior Fusion - Lumbar Laminectomy - Lumbar Posterolateral Fusion - Lumbar Interbody Fusion

Exclusion Criteria

  • 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 o The following drugs are alpha antagonists: alfuzosin, doxazosin, prazosin, terazosin, tamsulosin, and phenoxybenzamine. - Patients with history of allergy or sensitivity to tamsulosin or other alpha-antagonist - 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 o The following drugs are strong inhibitors of CYP3A4: ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir/ritonavir, lopinavir/ritonavir, and conivaptan. - Mental disability or prisoner - Pregnancy (for anesthesia purposes)

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment Group 		Neurosurgical patients undergoing decompressive laminectomy and/or spinal fusion who will receive uroselective alpha-1-adrenergic receptor antagonist Tamsulosin
  • Drug: Uroselective alpha-1-adrenergic receptor antagonist
    Subjects will receive Tamsulosin (0.4 mg daily) beginning 5 days prior to surgery and for the duration of the postoperative hospital stay (approximately 8-12 days)
    Other names:
    • Tamsulosin
Placebo Comparator
Control Group 		Neurosurgical patients undergoing decompressive laminectomy and/or spinal fusion who will receive a placebo
  • Other: Placebo
    Subjects will receive placebo beginning 5 days prior to surgery and for the duration of the postoperative hospital stay (approximately 8-12 days)

Recruiting Locations

Mayo Clinic in Rochester
Rochester, Minnesota 55905
Contact:
Neurologic Surgery Research Team
507-422-5673

More Details

Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

Neurologic Surgery Research Team
507-422-5673

Detailed Description

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 and prolonged hospital stays. With the addition of Tamsulosin, we 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.