Urinary Retention Postoperative
Conditions
Brief summary
The purpose of this research is to see if the use of tamsulosin can decrease both the incidence and duration of urinary retention, as well as hospital length of stay following spine surgery.
Detailed description
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 and prolonged hospital stays. With the addition of Tamsulosin, we 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.
Interventions
DRUGUroselective alpha-1-adrenergic receptor antagonist
Subjects will receive Tamsulosin (0.4 mg daily) beginning 5 days prior to surgery and for the duration of the postoperative hospital stay (approximately 8-12 days)
OTHERPlacebo
Subjects will receive placebo beginning 5 days prior to surgery and for the duration of the postoperative hospital stay (approximately 8-12 days)
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Cervical Laminectomy * Cervical Posterior Fusion * Cervical Anterior/Posterior Fusion * Lumbar Laminectomy * Lumbar Posterolateral Fusion * Lumbar Interbody Fusion
Exclusion criteria
* 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 o The following drugs are alpha antagonists: alfuzosin, doxazosin, prazosin, terazosin, tamsulosin, and phenoxybenzamine. * Patients with history of allergy or sensitivity to tamsulosin or other alpha-antagonist * 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 o The following drugs are strong inhibitors of CYP3A4: ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir/ritonavir, lopinavir/ritonavir, and conivaptan. * Mental disability or prisoner * Pregnancy (for anesthesia purposes)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of incidences of POUR (Postoperative urinary retention) | Post-operatively through end of hospital stay, approximately 8-12 days | Total number of incidences of POUR (Postoperative urinary retention). POUR is defined as any of the following: estimated post-void residual (PVR) volume of urine greater than or equal to 300 mL; estimated retention urine volume of greater than or equal to 500 mL in patients unable to void; or patients experiencing discomfort or distension and unable to void with lesser residual urine volume than 500 ml. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of POUR (Postoperative urinary retention) | Post-operatively through end of hospital stay, approximately 8-12 days | Duration subjects experience postoperative urinary retention, reported in days |
| Number of intermittent catheterizations in those with urinary retention | Post-operatively through end of hospital stay, approximately 8-12 days | Total number of catheterizations performed in subjects who experience urinary retention |
| Incidence of UTI (urinary tract infection) | Post-operatively through end of hospital stay, approximately 8-12 days | Number of subjects to be diagnosed with a UTI (urinary tract infection) post-operatively |
| Duration of hospital stay | Post-operatively through end of hospital stay, approximately 8-12 days | Total length of time subjects remain inpatient post-procedure, reported in days. |
Countries
United States
Contacts
CONTACTNeurologic Surgery Research Team
PRINCIPAL_INVESTIGATORMichelle Clarke, MD, PhD
Mayo Clinic
Outcome results
None listed