Decreasing Rates of Intraurethral Catheterization Postoperatively in Spine Surgery (DRIPS)

Anand Rughani, MD

Status and phase: Completed; Phase 4

Conditions: Post-operative Urinary Retention

Treatments: Drug: Placebo; Drug: Tamsulosin

Study type: Interventional

Funder types: Other

Identifiers

NCT02919436

IRB #4742

Details and patient eligibility

About

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

Full 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.

Enrollment: 610 patients

Sex: Male

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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610 participants in 2 patient groups, including a placebo group

Tamsulosin

Experimental group

Description:

Subjects in this arm will receive tamsulosin 0.4 mg/day for five days prior to surgery and two days after surgery.

Treatment:

Drug: Tamsulosin

Placebo

Placebo Comparator group

Description:

Subjects in this arm will receive a placebo capsule identical in appearance to the tamsulosin capsule, for five days prior to surgery and two days after surgery.

Treatment:

Drug: Placebo