Clinical trial NCT02919436: Decreasing Rates of Intraurethral Catheterization Postoperatively in Spine Surgery
Official title: Decreasing Rates of Intraurethral Catheterization Postoperatively in Spine Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-operative Urinary Retention
Lead sponsor: MaineHealth
Sponsor class: OTHER
Collaborators: name: MaineHealth
First posted: 2016-09-29
Enrollment: 610
Sex: MALE
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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

Primary outcomes:
measure: Number of Patients Who Undergo Postoperative Catheterization for Urinary Retention
timeFrame: Within 2 days after surgery
Secondary outcomes:
measure: Length of Stay
timeFrame: 0-7 days after surgery
measure: Number of Participants With or Without Postoperative Urinary Retention Based on Preoperative Post-void Residual
timeFrame: Within 2 days after surgery
Other outcomes:
Locations:
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
Study officials:
affiliation: MaineHealth
name: Anand Rughani, MD
role: PRINCIPAL_INVESTIGATOR
References: