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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02919436|
Recruitment Status : Recruiting
First Posted : September 29, 2016
Last Update Posted : September 29, 2016
|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)|
|Estimated Enrollment :||500 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|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2019|
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
- Decreased rate of urinary catheterization [ Time Frame: Within 2 days after surgery ]
- 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 ]
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
|Contact: Debbie Cushing, RN, MPH||207-885-4438|
|United States, Maine|
|Maine Medical Center||Recruiting|
|Portland, Maine, United States, 04102|
|Contact: Debbie Cushing, RN, MPH 207-885-4438 firstname.lastname@example.org|
|Principal Investigator: Anand Rughani, MD|
|Principal Investigator:||Anand Rughani, MD||Maine Medical Center|