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Trial record 39 of 52 for:    cushing's | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT02919436
Recruitment Status : Recruiting
First Posted : September 29, 2016
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):

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)
Estimated Enrollment : 500 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
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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. 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 ]

Eligibility Criteria

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
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

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


Contacts
Contact: Debbie Cushing, RN, MPH 207-885-4438

Locations
United States, Maine
Maine Medical Center Recruiting
Portland, Maine, United States, 04102
Contact: Debbie Cushing, RN, MPH    207-885-4438    cushid@mmc.org   
Principal Investigator: Anand Rughani, MD         
Sponsors and Collaborators
Maine Medical Center
Investigators
Principal Investigator: Anand Rughani, MD Maine Medical Center
More Information

Responsible Party: Anand Rughani, MD, Neurosurgeon, Maine Medical Center
ClinicalTrials.gov Identifier: NCT02919436     History of Changes
Other Study ID Numbers: IRB #4742
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: September 2016
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:
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