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NCT07174349 | RECRUITING | Urinary Retention Postoperative

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

Mayo Clinic

Information provided by (Responsible Party):

Michelle J. Clarke

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.

Condition or disease

Urinary Retention Postoperative

Intervention/treatment

Uroselective alpha-1-adrenergic receptor antagonist

Placebo

Phase

PHASE4

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 Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : The Use of an Uroselective Alpha-1-antagonist to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery
Actual Study Start Date : 2025-10-01
Estimated Primary Completion Date : 2027-12-31
Estimated Study Completion Date : 2028-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 35 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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)
Uroselective Alpha-1-Antagonist to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery

Location Details

NCT07174349

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Locations

RECRUITING

United States, Minnesota

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905