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

Mayo Clinic

Status and phase: Enrolling; Phase 4

Conditions: Urinary Retention Postoperative

Treatments: Drug: Uroselective alpha-1-adrenergic receptor antagonist; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07174349

24-005742

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Treatment Group

Experimental group

Description:

Neurosurgical patients undergoing decompressive laminectomy and/or spinal fusion who will receive uroselective alpha-1-adrenergic receptor antagonist Tamsulosin

Treatment:

Drug: Uroselective alpha-1-adrenergic receptor antagonist

Control Group

Placebo Comparator group

Description:

Neurosurgical patients undergoing decompressive laminectomy and/or spinal fusion who will receive a placebo

Treatment:

Other: Placebo