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

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

Study Overview

• Status: Completed
• Conditions: Post-operative Urinary Retention
• Intervention / Treatment: Drug: Tamsulosin; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 610
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tamsulosin; Subjects in this arm will receive tamsulosin 0.4 mg/day for five days prior to surgery and two days after surgery.	Drug: Tamsulosin; Active drug; Other Names: Flomax; Flomaxtra; Contiflo XL; Urimax
Placebo Comparator: 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.	Drug: Placebo; Lactose-filled capsules identical to active drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 2 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay	Length of hospital stay	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?	Within 2 days after surgery

Collaborators and Investigators

• Sponsor: Anand Rughani, MD
• Collaborators: MaineHealth
• Investigators: Principal Investigator: Anand Rughani, MD, MaineHealth

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): November 1, 2020

Study Registration Dates

• First Submitted: September 28, 2016
• First Submitted That Met QC Criteria: September 28, 2016
• First Posted (Estimate): September 29, 2016

Study Record Updates

• Last Update Posted (Actual): February 17, 2022
• Last Update Submitted That Met QC Criteria: January 27, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urination Disorders; Urinary Retention; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Tamsulosin
• Other Study ID Numbers: IRB #4742

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No