Decreasing Rates of Intraurethral Catheterization Postoperatively in Spine Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Urology |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 50 - 85 |
| Updated: | 4/17/2018 |
| Start Date: | March 2016 |
| End Date: | September 2020 |
| Contact: | Debbie Cushing, RN, MPH |
| Phone: | 207-885-4438 |
Randomization (1:1) of male patients, over age 50, undergoing elective spine surgery to
tamsulosin versus a placebo.
tamsulosin versus a placebo.
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.
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.
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
We found this trial at
1
site
22 Bramhall St
Portland, Maine 04102
Portland, Maine 04102
(207) 662-0111
Principal Investigator: Anand Rughani, MD
Phone: 207-885-4438
Maine Medical Center One of the country's consistently highest rated hospitals is right in your...
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