Uroselective Alpha-1-Antagonist to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery

Phase 4RecruitingNCT07174349

Mayo Clinic20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Urinary Retention Postoperative

Interventions

Uroselective alpha-1-adrenergic receptor antagonistDRUG

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)

PlaceboOTHER

Subjects will receive placebo beginning 5 days prior to surgery and for the duration of the postoperative hospital stay (approximately 8-12 days)

Eligibility

Sex: ALLMin age: 35 Years

Medical Language ↔ Plain English

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)

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

RECRUITING

Outcomes

Primary Outcomes

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.