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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. Identifier: NCT02919436
Recruitment Status : Completed
First Posted : September 29, 2016
Last Update Posted : November 20, 2020
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. Decreased rate of urinary catheterization [ Time Frame: Within 2 days after surgery ]

Secondary Outcome Measures :
  1. Length of stay [ Time Frame: 0-7 days after surgery ]
  2. Relationship between preoperative post-void residual and post-op urinary retention [ Time Frame: Within 2 days after surgery ]
  3. Correlation of baseline IPSS (International Prostate Symptom Score) and post-op urinary retention [ Time Frame: Within 2 days after surgery ]

Information from the National Library of Medicine

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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

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 identifier (NCT number): NCT02919436

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United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
Sponsors and Collaborators
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Principal Investigator: Anand Rughani, MD MaineHealth
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Responsible Party: Anand Rughani, MD, Neurosurgeon, MaineHealth Identifier: NCT02919436    
Other Study ID Numbers: IRB #4742
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Final results will be submitted to peer-reviewed journal for potential publication.
Additional relevant MeSH terms:
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Urinary Retention
Urination Disorders
Urologic Diseases
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