Recruiting

Tamsulosin

Sponsor:

Mayo Clinic

Code:

NCT07174349

Conditions

Urinary Retention Postoperative

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Not accepted

Interventions

Uroselective alpha-1-adrenergic receptor antagonist

Placebo

Study Details

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

Study ID

NCT07174349

Start date

Oct 1, 2026

Status verified date

Jun, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Group

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

placebo comparator: Control Group

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

Interventions

Uroselective alpha-1-adrenergic receptor antagonist

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)

Placebo

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

Primary outcome measure

  • Number of incidences of POUR (Postoperative urinary retention) [ Time Frame: Post-operatively through end of hospital stay, approximately 8-12 days ]

Central Contacts and Locations

Central contacts

Neurologic Surgery Research Team

507-422-5673

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Neurologic Surgery Research Team

507-422-5673

Principal Investigator:

Michelle J Clarke, MD, PhD

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-29.