Decreasing Rates of Intraurethral Catheterization Postoperatively in Spine Surgery

Post-operative Urinary Retention Clinical Trial

— DRIPS  

Official title:

Decreasing Rates of Intraurethral Catheterization Postoperatively in Spine Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02919436
• Other study ID #: IRB #4742
• Status: Completed
• Phase: Phase 4
• Start date: March 2016
• Est. completion date: November 2020

Study information

• Verified date: January 2022
• Source: MaineHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomization (1:1) of male patients, over age 50, undergoing elective spine surgery to tamsulosin versus a placebo.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 610
• Est. completion date: November 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Post-operative Urinary Retention
• Urinary Retention

Intervention

Drug:
• Tamsulosin
Active drug
• Placebo
Lactose-filled capsules identical to active drug

Locations

Country	Name	City	State
United States	Maine Medical Center	Portland	Maine

Sponsors (2)

Lead Sponsor	Collaborator
Anand Rughani, MD	MaineHealth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Who Undergo Postoperative Catheterization for Urinary Retention	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.	Within 2 days after surgery
Secondary	Length of Stay	Length of hospital stay	0-7 days after surgery
Secondary	Number of Participants With or Without Postoperative Urinary Retention Based on Preoperative Post-void Residual	Was post-void residual greater than 50 cc when measured at the preoperative office visit associated with postoperative urinary retention?	Within 2 days after surgery