Phase 4
N=610
Decreasing Rates of Intraurethral Catheterization Postoperatively in Spine Surgery
Post-operative Urinary Retention
Bottom Line
View on ClinicalTrials.gov: NCT02919436 ↗Enrolled (actual)
610
Serious AEs
1.8%
Results posted
Feb 2022
Primary outcome: Primary: Number of Patients Who Undergo Postoperative Catheterization for Urinary Retention — 23; 25 Participants — p=.96
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tamsulosin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Male
- Sponsor
- Anand Rughani, MD
- Primary completion
- Jan 2020
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 | — |
Summary
Randomization (1:1) of male patients, over age 50, undergoing elective spine surgery to tamsulosin versus a placebo.
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
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.