Decreasing Rates of Intraurethral Catheterization Postoperatively in Spine Surgery

Phase 4CompletedNCT02919436

Anand Rughani, MD610 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

610

Conditions

Post-operative Urinary Retention

Interventions

TamsulosinDRUG

Active drug

PlaceboDRUG

Lactose-filled capsules identical to active drug

Eligibility

Sex: MALEMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Maine Medical Center

Portland, Maine, United States

Outcomes

Primary Outcomes

Number of Patients Who Undergo Postoperative Catheterization for Urinary Retention

Postoperative urinary retention was defined as the need for any postoperative urinary catheterization for acute retention. Per hospital protocol, failure to void 6 hours after surgery or development of bladder discomfort required bladder scan. If bladder volume exceeded 300 cc, catheterization was performed.

Time frame: Within 2 days after surgery

Secondary Outcomes

Length of Stay

Length of hospital stay

Time frame: 0-7 days after surgery

Number of Participants With or Without Postoperative Urinary Retention Based on Preoperative Post-void Residual

Was post-void residual greater than 50 cc when measured at the preoperative office visit associated with postoperative urinary retention?

Time frame: Within 2 days after surgery

Data from ClinicalTrials.gov

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