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

Not Applicable

Recruiting

• Conditions: Urinary Retention Postoperative
• Interventions: Drug: Uroselective alpha-1-adrenergic receptor antagonist; Other: Placebo

• Registration Number: NCT07174349
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-12
• Study First Submitted QC: 2025-09-12
• Last Update Submitted: 2025-09-12
• Study First Posted: 2025-09-15
• Last Update Posted: 2025-09-15
• Study Start: 2025-10-01
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Uroselective alpha-1-adrenergic receptor antagonist	Neurosurgical patients undergoing decompressive laminectomy and/or spinal fusion who will receive uroselective alpha-1-adrenergic receptor antagonist Tamsulosin
Control Group	Placebo	Neurosurgical patients undergoing decompressive laminectomy and/or spinal fusion who will receive a placebo

Primary Outcome Measures

Name	Time	Method
Number of incidences of POUR (Postoperative urinary retention)	Post-operatively through end of hospital stay, approximately 8-12 days	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.

Secondary Outcome Measures

Name	Time	Method
Duration of POUR (Postoperative urinary retention)	Post-operatively through end of hospital stay, approximately 8-12 days	Duration subjects experience postoperative urinary retention, reported in days
Number of intermittent catheterizations in those with urinary retention	Post-operatively through end of hospital stay, approximately 8-12 days	Total number of catheterizations performed in subjects who experience urinary retention
Incidence of UTI (urinary tract infection)	Post-operatively through end of hospital stay, approximately 8-12 days	Number of subjects to be diagnosed with a UTI (urinary tract infection) post-operatively
Duration of hospital stay	Post-operatively through end of hospital stay, approximately 8-12 days	Total length of time subjects remain inpatient post-procedure, reported in days.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States