Clinical trial NCT01568918: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Postoperative Urinary Retention
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-04-02
Enrollment: 90
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence of Postoperative Urinary Retention
timeFrame: participants will be followed for the duration of the hospital stay, an expected average of 5 days
Secondary outcomes:
measure: Duration of Postoperative Urinary Retention
timeFrame: participants will be followed for the duration of the hospital stay, an expected average of 5 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michelle Clarke, MD
role: PRINCIPAL_INVESTIGATOR
References: