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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Neurosurgical patients undergoing decompressive laminectomy and/or spinal fusion who will receive uroselective alpha-1-adrenergic receptor antagonist Tamsulosin |
|
| Control Group | Placebo Comparator | Neurosurgical patients undergoing decompressive laminectomy and/or spinal fusion who will receive a placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Uroselective alpha-1-adrenergic receptor antagonist | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post-operatively through end of hospital stay, approximately 8-12 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of POUR (Postoperative urinary retention) | Duration subjects experience postoperative urinary retention, reported in days | Post-operatively through end of hospital stay, approximately 8-12 days |
| Number of intermittent catheterizations in those with urinary retention |
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Inclusion Criteria:
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)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Neurologic Surgery Research Team | Contact | 507-422-5673 |
| Name | Affiliation | Role |
|---|---|---|
| Michelle Clarke, MD, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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|
| Placebo | Other | Subjects will receive placebo beginning 5 days prior to surgery and for the duration of the postoperative hospital stay (approximately 8-12 days) |
|
Total number of catheterizations performed in subjects who experience urinary retention |
| 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 | 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. | Post-operatively through end of hospital stay, approximately 8-12 days |
| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
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