Use of Tamsulosin to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery

Postoperative Urinary Retention Clinical Trial

Official title:

The Use of an Uroselective Alpha-1-antagonist to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01568918
• Other study ID #: 11-006704
• Status: Recruiting
• Phase: Phase 3
• Start date: May 2012
• Est. completion date: December 2023

Study information

• Verified date: February 2023
• Source: Mayo Clinic
• Contact: Bambi Wessel
• Phone: 507-293-1963
• Email: Wessel.Bambi[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Postoperative urinary retention is a frequent complication of spinal surgeries and impacts a large portion of this population which results in increased morbidity as a result of increased number of catheterizations, urinary tract infections (UTIs) and prolonged hospital stays. With the addition of Tamsulosin, the investigators would anticipate a reduction in the incidence and duration of postoperative urinary retention and therefore a reduction in morbidity related to treatment of urinary retention as well as shortened hospital stays.

Description:

Decompressive laminectomy and spinal fusion procedures are among the most common neurosurgical procedures performed. Postoperative urinary retention (POUR) is a frequent complication of such surgeries and impacts a large proportion of this population resulting in multiple intermittent bladder catheterizations for bladder decompression, increased incidence of bacteremia, increased incidence of UTIs, and prolonged hospital stays. Use of a uroselective alpha-1-adrenergic receptor antagonist, such as tamsulosin, in the perioperative period (medication started five days prior to surgery and taken until hospital discharge) could reduce both the incidence and duration of postoperative urinary retention, resulting in shorter hospital stays and decreased healthcare costs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

Inclusion Criteria

• = 35 years (Males & Females)
• Cervical Laminectomy
• Cervical Posterior Fusion
• Cervical Anterior/Posterior Fusion
• Lumbar Laminectomy
• Lumbar Posterolateral Fusion
• Lumbar Interbody Fusion Exclusion Criteria
• < 35 years
• Cervical Anterior Discectomy and Fusion
• Cervical Anterior Corpectomy
• Cervical Posterior Discectomy
• Cervical Foraminotomy
• Lumbar Discectomy (METRx or Open)
• Lumbar Foraminotomy
• Lumbar Anterior Fusion
• Myelopathy with bladder dysfunction
• Patients currently taking an alpha-antagonist
• Patients with history of allergy or sensitivity to tamsulosin or other alpha-antagonist (alfuzosin, doxazosin, prazosin, terazosin, tamsulosin, and phenoxybenzamine)
• History of prostatectomy or urologic surgery involving the bladder or urethra
• Severe liver disease or end-stage renal disease
• Patients taking strong inhibitors of CYP3A4 (ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir/ritonavir, lopinavir/ritonavir, and conivaptan)
• Patients with a mental disability
• Prisoners

Related Conditions & MeSH terms

• Postoperative Urinary Retention
• Urinary Retention

Intervention

Drug:
• Tamsulosin hydrochloride
Participants will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge.

Other:
• Placebo
The placebo capsule matching the active study drug will be given daily from 5 days prior to the operation until hospital discharge.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative urinary retention	Post operative urinary retention (POUR) will be defined as any of the following: 1) Estimated post-void residual (PVR) volume of urine greater than or equal to 300 mL; 2) Estimated retention urine volume of greater than or equal to 500 mL in patients unable to void; 3) Patients experiencing discomfort or distension and unable to void with lesser residual urine volume than 500 ml.	participants will be followed for the duration of the hospital stay, an expected average of 5 days
Secondary	Duration of postoperative urinary retention	The neurosurgical team will decide if an indwelling urinary catheter will be used. Time of indwelling catheter removal after surgery will serve as time zero for beginning calculation of postoperative urinary retention duration if the patient later requires in and out straight catheterization. For patients without an indwelling catheter, the time patients leave the operating room will serve as time zero. Urinary retention will be considered resolved after two consecutive post-void residual urine scans have demonstrated less than 300 ml residual urine volume in a patient spontaneously voiding.	participants will be followed for the duration of the hospital stay, an expected average of 5 days

External Links

•   Mayo Clinic Clinical Trials