Tamsulosin to prevent and shorten postoperative urinary retention after spine surgery
The Use of an Uroselective Alpha-1-antagonist to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery
This trial will test whether taking tamsulosin around the time of spine surgery can reduce how often patients have urinary retention and how long it lasts.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 35 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT07174349 on ClinicalTrials.gov |
What this trial studies
Adults undergoing specified cervical or lumbar decompression and fusion procedures will be randomized to receive a uroselective alpha-1 antagonist (tamsulosin) or matching placebo around the time of surgery. The study measures the incidence and duration of postoperative urinary retention, need for catheterizations, urinary tract infections, and hospital length of stay. Key exclusions include patients with preexisting bladder dysfunction, prior urologic surgery, current alpha-blocker use, significant liver or end-stage renal disease, and several excluded spine procedures. The trial is a Phase 4 interventional study conducted at Mayo Clinic in Rochester, MN.
Who should consider this trial
Good fit: Adults scheduled for specified cervical or lumbar laminectomy or fusion procedures who are not already taking alpha-antagonists and do not have excluded urologic or severe organ disease are ideal candidates.
Not a fit: Patients undergoing excluded spine procedures, those with myelopathy-related bladder dysfunction, prior prostatectomy/urologic surgery, current alpha-antagonist use, or severe liver/renal disease are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, patients could experience fewer catheterizations and urinary infections and leave the hospital sooner after spine surgery.
How similar studies have performed: Prior trials and meta-analyses of alpha-blockers for postoperative urinary retention in various surgical populations have shown mixed but often favorable results, so the approach has some supporting evidence.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Michelle Clarke, MD, PhD — Mayo Clinic
- Study coordinator: Neurologic Surgery Research Team
- Phone: 507-422-5673
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.