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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
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Anand Rughani, MD, MaineHealth

Tracking Information
First Submitted Date  ICMJE September 28, 2016
First Posted Date  ICMJE September 29, 2016
Last Update Posted Date November 20, 2020
Study Start Date  ICMJE March 2016
Actual Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2016)
Decreased rate of urinary catheterization [ Time Frame: Within 2 days after surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2016)
  • Length of stay [ Time Frame: 0-7 days after surgery ]
  • Relationship between preoperative post-void residual and post-op urinary retention [ Time Frame: Within 2 days after surgery ]
  • Correlation of baseline IPSS (International Prostate Symptom Score) and post-op urinary retention [ Time Frame: Within 2 days after surgery ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Decreasing Rates of Intraurethral Catheterization Postoperatively in Spine Surgery
Official Title  ICMJE Decreasing Rates of Intraurethral Catheterization Postoperatively in Spine Surgery
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Post-operative Urinary Retention
Intervention  ICMJE
  • Drug: Tamsulosin
    Active drug
    Other Names:
    • Flomax
    • Flomaxtra
    • Contiflo XL
    • Urimax
  • Drug: Placebo
    Lactose-filled capsules identical to active drug
Study Arms  ICMJE
  • Experimental: Tamsulosin
    Subjects in this arm will receive tamsulosin 0.4 mg/day for five days prior to surgery and two days after surgery.
    Intervention: Drug: Tamsulosin
  • 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.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 18, 2020)
610
Original Estimated Enrollment  ICMJE
 (submitted: September 28, 2016)
500
Actual Study Completion Date  ICMJE November 2020
Actual Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02919436
Other Study ID Numbers  ICMJE IRB #4742
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Final results will be submitted to peer-reviewed journal for potential publication.
Responsible Party Anand Rughani, MD, MaineHealth
Study Sponsor  ICMJE MaineHealth
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anand Rughani, MD MaineHealth
PRS Account MaineHealth
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP