A Phase 4 interventional study of Uroselective alpha-1-adrenergic receptor antagonist and Placebo in Urinary Retention Postoperative, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Mayo Clinic · Phase 4, Interventional, and Treatment
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.
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.
Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients currently taking an alpha-antagonist
o The following drugs are alpha antagonists: alfuzosin, doxazosin, prazosin, terazosin, tamsulosin, and phenoxybenzamine.
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.
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
Neurosurgical patients undergoing decompressive laminectomy and/or spinal fusion who will receive a placebo
Other: Placebo
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)
Also known as: Tamsulosin
Subjects will receive placebo beginning 5 days prior to surgery and for the duration of the postoperative hospital stay (approximately 8-12 days)
Number of incidences of POUR (Postoperative urinary retention)
Total number of incidences of POUR (Postoperative urinary retention). POUR is defined as any of the following: estimated post-void residual (PVR) volume of urine greater than or equal to 300 mL; estimated retention urine volume of greater than or equal to 500 mL in patients unable to void; or patients experiencing discomfort or distension and unable to void with lesser residual urine volume than 500 ml.
Time frame: Post-operatively through end of hospital stay, approximately 8-12 days
Duration of POUR (Postoperative urinary retention)
Duration subjects experience postoperative urinary retention, reported in days
Time frame: Post-operatively through end of hospital stay, approximately 8-12 days
Number of intermittent catheterizations in those with urinary retention
Total number of catheterizations performed in subjects who experience urinary retention
Time frame: Post-operatively through end of hospital stay, approximately 8-12 days
Incidence of UTI (urinary tract infection)
Number of subjects to be diagnosed with a UTI (urinary tract infection) post-operatively
Time frame: Post-operatively through end of hospital stay, approximately 8-12 days
Duration of hospital stay
Total length of time subjects remain inpatient post-procedure, reported in days.
Time frame: Post-operatively through end of hospital stay, approximately 8-12 days
Plan to share: No
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