NCT02919436

Decreasing Rates of Intraurethral Catheterization Postoperatively in Spine Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 610 (actual)
• Sponsor: Anand Rughani, MD · Academic / Other
• Sex: Male
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Postoperative urinary retention (POUR) is a common complication following certain surgical operations. While much is known about the innervation and neural regulation of bladder emptying and storage, the cause of urinary retention after surgery is not fully understood. Early research has indicated that a small dose of tamsulosin (Flomax®), a commonly used medication approved to treat urinary symptoms in men with benign prostatic hypertrophy, may reduce the incidence of POUR. Urinary retention is a prevalent issue in patients undergoing spinal surgery, leading to patient discomfort and prolonged length of stay. We hypothesize that the use of perioperative tamsulosin in patients undergoing spinal surgery will decrease the incidence of POUR. The study is a prospective, double-blind, randomized, placebo-controlled trial. Subjects will be randomized 1:1 to receive either oral tamsulosin 0.4 mg or placebo, taken once each evening, beginning 5 days prior to surgery and continuing through the first postoperative day. The primary endpoint is met when the patient is able to spontaneously empty their bladder post-operatively, or needs to be catheterized with either a straight or indwelling urinary catheter for post-operative urinary retention, whichever occurs first.

Conditions

• Post-operative Urinary Retention

Interventions

Type	Name	Description
DRUG	Tamsulosin	Active drug
DRUG	Placebo	Lactose-filled capsules identical to active drug

Timeline

• Start date: 2016-03-01
• Primary completion: 2020-01-01
• Completion: 2020-11-01
• First posted: 2016-09-29
• Last updated: 2022-02-17
• Results posted: 2022-02-17

Locations

1 site across 1 country: United States