Use of Tamsulosin to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery
Last updated on April 2022Recruitment
- Recruitment Status
- Recruiting
Inclusion Criteria
- Cervical Anterior/Posterior Fusion
- Lumbar Interbody Fusion
- ≥ 35 years (Males & Females)
- ...
- Cervical Anterior/Posterior Fusion
- Lumbar Interbody Fusion
- ≥ 35 years (Males & Females)
- Lumbar Laminectomy
- Cervical Posterior Fusion
- Cervical Laminectomy
- Lumbar Posterolateral Fusion
Exclusion Criteria
- Lumbar Foraminotomy
- Myelopathy with bladder dysfunction
- Lumbar Anterior Fusion
- ...
- Lumbar Foraminotomy
- Myelopathy with bladder dysfunction
- Lumbar Anterior Fusion
- Cervical Foraminotomy
- < 35 years
- Cervical Posterior Discectomy
- Patients with history of allergy or sensitivity to tamsulosin or other alpha-antagonist (alfuzosin, doxazosin, prazosin, terazosin, tamsulosin, and phenoxybenzamine)
- Cervical Anterior Corpectomy
- Patients taking strong inhibitors of CYP3A4 (ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir/ritonavir, lopinavir/ritonavir, and conivaptan)
- Severe liver disease or end-stage renal disease
- Prisoners
- Cervical Anterior Discectomy and Fusion
- Patients currently taking an alpha-antagonist
- History of prostatectomy or urologic surgery involving the bladder or urethra
- Patients with a mental disability
- Lumbar Discectomy (METRx or Open)
Summary
- Conditions
- Postoperative Urinary Retention
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
Participation Requirements
- Age
- Between 35 years and 125 years
- Gender
- Both males and females
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 cathet...
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.
Inclusion Criteria
- Cervical Anterior/Posterior Fusion
- Lumbar Interbody Fusion
- ≥ 35 years (Males & Females)
- ...
- Cervical Anterior/Posterior Fusion
- Lumbar Interbody Fusion
- ≥ 35 years (Males & Females)
- Lumbar Laminectomy
- Cervical Posterior Fusion
- Cervical Laminectomy
- Lumbar Posterolateral Fusion
Exclusion Criteria
- Lumbar Foraminotomy
- Myelopathy with bladder dysfunction
- Lumbar Anterior Fusion
- ...
- Lumbar Foraminotomy
- Myelopathy with bladder dysfunction
- Lumbar Anterior Fusion
- Cervical Foraminotomy
- < 35 years
- Cervical Posterior Discectomy
- Patients with history of allergy or sensitivity to tamsulosin or other alpha-antagonist (alfuzosin, doxazosin, prazosin, terazosin, tamsulosin, and phenoxybenzamine)
- Cervical Anterior Corpectomy
- Patients taking strong inhibitors of CYP3A4 (ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir/ritonavir, lopinavir/ritonavir, and conivaptan)
- Severe liver disease or end-stage renal disease
- Prisoners
- Cervical Anterior Discectomy and Fusion
- Patients currently taking an alpha-antagonist
- History of prostatectomy or urologic surgery involving the bladder or urethra
- Patients with a mental disability
- Lumbar Discectomy (METRx or Open)
Tracking Information
- NCT #
- NCT01568918
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Michelle Clarke, MD Mayo Clinic
- Michelle Clarke, MD Mayo Clinic
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