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Recruiting NCT07174349

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

Phase IV Interventional Urinary Retention Postoperative

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Uroselective alpha-1-adrenergic receptor antagonist, Placebo.
Who it may be relevant to
Registry conditions: Urinary Retention Postoperative. Basic parameters: from 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug 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)
  • Other 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 measures

  • Number of incidences of POUR (Postoperative urinary retention) [Time frame: Post-operatively through end of hospital stay, approximately 8-12 days]
Secondary outcome measures (4)
  • Duration of POUR (Postoperative urinary retention) [Time frame: Post-operatively through end of hospital stay, approximately 8-12 days]
  • Number of intermittent catheterizations in those with urinary retention [Time frame: Post-operatively through end of hospital stay, approximately 8-12 days]
  • Incidence of UTI (urinary tract infection) [Time frame: Post-operatively through end of hospital stay, approximately 8-12 days]
  • Duration of hospital stay [Time frame: Post-operatively through end of hospital stay, approximately 8-12 days]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT07174349 · 24-005742

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗