Decreasing Rates of Intraurethral Catheterization Postoperatively in Spine Surgery (DRIPS)
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|ClinicalTrials.gov Identifier: NCT02919436|
Recruitment Status : Completed
First Posted : September 29, 2016
Results First Posted : February 17, 2022
Last Update Posted : February 17, 2022
|Condition or disease||Intervention/treatment||Phase|
|Post-operative Urinary Retention||Drug: Tamsulosin Drug: Placebo||Phase 4|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||610 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
Subjects in this arm will receive tamsulosin 0.4 mg/day for five days prior to surgery and two days after surgery.
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.
Lactose-filled capsules identical to active drug
- 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.
- Length of Stay [ Time Frame: 0-7 days after surgery ]Length of hospital stay
- 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?
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
|United States, Maine|
|Maine Medical Center|
|Portland, Maine, United States, 04102|
|Principal Investigator:||Anand Rughani, MD||MaineHealth|