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Randomization (1:1) of male patients, over age 50, undergoing elective spine surgery to tamsulosin versus a placebo.
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.
Age
50 - 85 years
Sex
MALE
Healthy Volunteers
No
Maine Medical Center
Portland, Maine, United States
Start Date
March 1, 2016
Primary Completion Date
January 1, 2020
Completion Date
November 1, 2020
Last Updated
February 17, 2022
610
ACTUAL participants
Tamsulosin
DRUG
Placebo
DRUG
Lead Sponsor
Anand Rughani, MD
Collaborators
Data Source & Attribution
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