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

• ClinicalTrials.gov Identifier: NCT02919436
• Recruitment Status: Completed
• First Posted: September 29, 2016
• Results First Posted: February 17, 2022
• Last Update Posted: February 17, 2022
• Sponsor: Anand Rughani, MD
• Collaborator: MaineHealth
• Information provided by (Responsible Party): Anand Rughani, MD, MaineHealth

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Post-operative Urinary Retention	Drug: Tamsulosin; Drug: Placebo	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 610 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: Decreasing Rates of Intraurethral Catheterization Postoperatively in Spine Surgery
• Study Start Date: March 2016
• Actual Primary Completion Date: January 2020
• Actual Study Completion Date: November 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Number of Patients Who Undergo Postoperative Catheterization for Urinary Retention [ Time Frame: Within 2 days after surgery ]
   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.

Secondary Outcome Measures :

1. Length of Stay [ Time Frame: 0-7 days after surgery ]
   Length of hospital stay
2. Number of Participants With or Without Postoperative Urinary Retention Based on Preoperative Post-void Residual [ Time Frame: Within 2 days after surgery ]
   Was post-void residual greater than 50 cc when measured at the preoperative office visit associated with postoperative urinary retention?

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Maine

Maine Medical Center

Portland, Maine, United States, 04102

Sponsors and Collaborators

Anand Rughani, MD

MaineHealth

Investigators

• Principal Investigator: Anand Rughani, MD; MaineHealth

  Study Documents (Full-Text)

Documents provided by Anand Rughani, MD, MaineHealth:

Study Protocol and Statistical Analysis Plan  [PDF] September 3, 2019

More Information

• Responsible Party: Anand Rughani, MD, Neurosurgeon, MaineHealth
• ClinicalTrials.gov Identifier: NCT02919436
• Other Study ID Numbers: IRB #4742
• First Posted: September 29, 2016
• Results First Posted: February 17, 2022
• Last Update Posted: February 17, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Urinary Retention; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Tamsulosin; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Urological Agents