Use of Tamsulosin to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Postoperative Urinary Retention |
Drug: Tamsulosin hydrochloride Other: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | The Use of an Uroselective Alpha-1-antagonist to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery |
- Incidence of postoperative urinary retention [ Time Frame: participants will be followed for the duration of the hospital stay, an expected average of 5 days ] [ Designated as safety issue: No ]
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.
- Duration of postoperative urinary retention [ Time Frame: participants will be followed for the duration of the hospital stay, an expected average of 5 days ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 350 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Tamsulosin
Participants randomized to this arm will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge.
|
Drug: Tamsulosin hydrochloride
Participants will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge.
Other Names:
|
|
Placebo Comparator: Placebo
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.
|
Other: Placebo
The placebo capsule matching the active study drug will be given daily from 5 days prior to the operation until hospital discharge.
|
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.
Eligibility| Ages Eligible for Study: | 35 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Steven D Thalacker, RN | 507-255-7906 | thals@mayo.edu |
| United States, Minnesota | |
| Mayo Clinic in Rochester | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Steve Thalacker, RN 507-255-7906 thals@mayo.edu | |
| Contact: Sandra Twaites 507-284-5775 twaites.sandra@mayo.edu | |
| Principal Investigator: | Michelle Clarke, MD | Mayo Clinic |
More Information
Additional Information:
No publications provided
| Responsible Party: | Michelle J. Clarke, Principal Investigator, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT01568918 History of Changes |
| Other Study ID Numbers: | 11-006704 |
| Study First Received: | March 13, 2012 |
| Last Updated: | March 5, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Urinary Retention Urination Disorders Urologic Diseases Tamsulosin Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists |
Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013