Phase 4 Completed N=610 Randomized Triple-blind Prevention

Decreasing Rates of Intraurethral Catheterization Postoperatively in Spine Surgery

Post-operative Urinary Retention

Source: ClinicalTrials.gov NCT02919436 ↗

Enrolled (actual)

610

Serious AEs

1.8%

Results posted

Feb 2022

Primary outcomePrimary: Number of Patients Who Undergo Postoperative Catheterization for Urinary Retention — 23; 25 Participants — p=.96

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

Randomization (1:1) of male patients, over age 50, undergoing elective spine surgery to tamsulosin versus a placebo.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients Who Undergo Postoperative Catheterization for Urinary Retention	23; 25	.96
SECONDARY Length of Stay	0.9; 0.7	—
SECONDARY Number of Participants With or Without Postoperative Urinary Retention Based on Preoperative Post-void Residual	18; 22; 273; 134	—

Eligibility Criteria

Inclusion Criteria

Male patient age 50 - 85 years
Undergoing elective spine surgery at least 5 days after enrollment
Preop visit done at office practice

Exclusion Criteria

Currently on tamsulosin or other alpha-adrenergic blocking drug
Allergy to tamsulosin
Allergy to lactose
Serious or life-threatening allergy to sulfa drugs
Emergent procedure
History of spinal trauma, spinal infection or spinal cord tumor
Pre-existing indwelling urinary catheter
History of orthostatic hypotension or current orthostatic hypotension
History of prostate, urethral or bladder surgery
Renal failure
Non-English speaking
Unable to provide informed consent

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02919436). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.