Use of Tamsulosin to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery
Primary Purpose
Postoperative Urinary Retention
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tamsulosin hydrochloride
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Urinary Retention
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic in RochesterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tamsulosin
Placebo
Arm Description
Participants randomized to this arm will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge.
Participants randomized to this arm will receive a daily placebo capsule matching the active study drug from 5 days prior to the operation until hospital discharge.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01568918
Brief Title
Use of Tamsulosin to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery
Official Title
The Use of an Uroselective Alpha-1-antagonist to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Urinary Retention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
350 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tamsulosin
Arm Type
Experimental
Arm Description
Participants randomized to this arm will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants randomized to this arm will receive a daily placebo capsule matching the active study drug from 5 days prior to the operation until hospital discharge.
Intervention Type
Drug
Intervention Name(s)
Tamsulosin hydrochloride
Other Intervention Name(s)
Flomax, Flomaxtra, Contiflo XL, Urimax
Intervention Description
Participants will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The placebo capsule matching the active study drug will be given daily from 5 days prior to the operation until hospital discharge.
Primary Outcome Measure Information:
Title
Incidence of postoperative urinary retention
Description
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.
Time Frame
participants will be followed for the duration of the hospital stay, an expected average of 5 days
Secondary Outcome Measure Information:
Title
Duration of postoperative urinary retention
Description
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.
Time Frame
participants will be followed for the duration of the hospital stay, an expected average of 5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bambi Wessel
Phone
507-293-1963
Email
Wessel.Bambi@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Clarke, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://clinicaltrials.mayo.edu
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Use of Tamsulosin to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery
We'll reach out to this number within 24 hrs