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

NCT07174349 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 24-005742
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Retention Postoperative

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Duration of POUR (Postoperative urinary retention)

  Post-operatively through end of hospital stay, approximately 8-12 days

• Number of intermittent catheterizations in those with urinary retention

  Post-operatively through end of hospital stay, approximately 8-12 days

• Incidence of UTI (urinary tract infection)

  Post-operatively through end of hospital stay, approximately 8-12 days

• Duration of hospital stay

  Post-operatively through end of hospital stay, approximately 8-12 days

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Control Group

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

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)

Also known as: Tamsulosin

Treatment Group

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)

Control Group

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cervical Laminectomy
• Cervical Posterior Fusion
• Cervical Anterior/Posterior Fusion
• Lumbar Laminectomy
• Lumbar Posterolateral Fusion
• Lumbar Interbody Fusion

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Tamsulosin

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Michelle Clarke, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neurologic Surgery Research Team

CONTACT

507-422-5673

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 15, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)