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NCT Number: NCT07174349

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

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.

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Key information

Conditions

Urinary Retention Postoperative

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Michelle J Clarke, MD, PhD

PRINCIPAL_INVESTIGATOR

Neurologic Surgery Research Team

CONTACT

507-422-5673

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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)

Other names: Tamsulosin

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)

Primary outcomes

  1. Number of incidences of POUR (Postoperative urinary retention)

    Time frame: 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 outcomes

  1. Duration of POUR (Postoperative urinary retention)

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

    Duration subjects experience postoperative urinary retention, reported in days

  2. Number of intermittent catheterizations in those with urinary retention

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

    Total number of catheterizations performed in subjects who experience urinary retention

  3. Incidence of UTI (urinary tract infection)

    Time frame: 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

  4. Duration of hospital stay

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

    Total length of time subjects remain inpatient post-procedure, reported in days.

Study contacts

Contact information is provided by the study sponsor or research team.

Neurologic Surgery Research Team

CONTACT

507-422-5673

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

The Use of an Uroselective Alpha-1-antagonist to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 15, 2025
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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