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
Verified date | May 2024 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 90 |
Est. completion date | November 21, 2019 |
Est. primary completion date | November 21, 2019 |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
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 |
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