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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Collaborator:
MaineHealth
Information provided by (Responsible Party):
Anand Rughani, MD, MaineHealth

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.

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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

Resource links provided by the National Library of Medicine


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




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?



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02919436


Locations
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United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
Sponsors and Collaborators
Anand Rughani, MD
MaineHealth
Investigators
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Principal Investigator: Anand Rughani, MD MaineHealth
  Study Documents (Full-Text)

Documents provided by Anand Rughani, MD, MaineHealth:
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Responsible Party: Anand Rughani, MD, Neurosurgeon, MaineHealth
ClinicalTrials.gov Identifier: NCT02919436    
Other Study ID Numbers: IRB #4742
First Posted: September 29, 2016    Key Record Dates
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:
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Urinary Retention
Urination Disorders
Urologic 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