Decreasing Rates of Intraurethral Catheterization Postoperatively in Spine Surgery

NCT ID: NCT02919436

Last Updated: 2022-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 610 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2020-11-30

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.

Conditions

Post-operative Urinary Retention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Tamsulosin

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

Group Type: EXPERIMENTAL

Tamsulosin

Intervention Type: DRUG

Active drug

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Lactose-filled capsules identical to active drug

Interventions

Tamsulosin

Active drug

Intervention Type: DRUG

Placebo

Lactose-filled capsules identical to active drug

Intervention Type: DRUG

Other Intervention Names

Flomax; Flomaxtra; Contiflo XL; Urimax

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

MaineHealth

OTHER

Sponsor Role: collaborator

Anand Rughani, MD

OTHER

Sponsor Role: lead

Responsible Party

Anand Rughani, MD

Neurosurgeon

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Anand Rughani, MD

Role: PRINCIPAL_INVESTIGATOR

MaineHealth

Locations

Maine Medical Center

Portland, Maine, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB #4742

Identifier Type: -

Identifier Source: org_study_id