Postoperative Urinary Retention
Conditions
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.
Interventions
Participants will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge.
OTHERPlacebo
The placebo capsule matching the active study drug will be given daily from 5 days prior to the operation until hospital discharge.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Urinary Retention | participants will be followed for the duration of the hospital stay, an expected average of 5 days | 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
| Measure | Time frame | Description |
|---|---|---|
| Duration of Postoperative Urinary Retention | participants will be followed for the duration of the hospital stay, an expected average of 5 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tamsulosin Participants randomized to this arm will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge.
Tamsulosin hydrochloride: Participants will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge. | 39 |
| 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.
Placebo: The placebo capsule matching the active study drug will be given daily from 5 days prior to the operation until hospital discharge. | 51 |
| Total | 90 |
Baseline characteristics
| Characteristic | Total | Tamsulosin | Placebo |
|---|---|---|---|
| Age, Continuous | 62.47 years STANDARD_DEVIATION 10.12 | 61.04 years STANDARD_DEVIATION 10.36 | 63.59 years STANDARD_DEVIATION 9.91 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 90 Participants | 39 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 90 Participants | 39 Participants | 51 Participants |
| Region of Enrollment United States | 90 participants | 39 participants | 51 participants |
| Sex: Female, Male Female | 35 Participants | 15 Participants | 20 Participants |
| Sex: Female, Male Male | 55 Participants | 24 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 51 |
| other Total, other adverse events | 0 / 39 | 1 / 51 |
| serious Total, serious adverse events | 0 / 39 | 0 / 51 |
Outcome results
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.
Time frame: participants will be followed for the duration of the hospital stay, an expected average of 5 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tamsulosin | Incidence of Postoperative Urinary Retention | 11 Participants |
| Placebo | Incidence of Postoperative Urinary Retention | 20 Participants |
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.
Time frame: participants will be followed for the duration of the hospital stay, an expected average of 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tamsulosin | Duration of Postoperative Urinary Retention | 3.42 days | Standard Deviation 0.932 |
| Placebo | Duration of Postoperative Urinary Retention | 3.52 days | Standard Deviation 1.21 |