A Phase 3 interventional study of Tamsulosin hydrochloride and Placebo in Postoperative Urinary Retention, sponsored by Mayo Clinic. Terminated at 1 site in United States. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2024-05-30.
Sponsored by Mayo Clinic · Phase 3, Interventional, and Prevention
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.
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.
235 studies on the registry are indexed under Urinary Retention; 39 are open to participants now.
This study's enrollment of 90 is close to the median of 95 across 185 interventional studies indexed under Urinary Retention.
Browse Urinary Retention studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
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Exclusion Criteria
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 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
Participants will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge.
Also known as: Flomax, Flomaxtra, Contiflo XL, Urimax
The placebo capsule matching the active study drug will be given daily from 5 days prior to the operation until hospital discharge.
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
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
| Milestone | Tamsulosin | Placebo |
|---|---|---|
| Started | 39 | 51 |
| Completed | 39 | 51 |
| Not completed | 0 | 0 |
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 | Tamsulosin | Placebo |
|---|---|---|
| Incidence of Postoperative Urinary Retention | 11 | 20 |
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.
| days | Tamsulosin | Placebo |
|---|---|---|
| Duration of Postoperative Urinary Retention | 3.42 ± 0.932 | 3.52 ± 1.210 |
Collected over Adverse events were collected from baseline to first follow-up postop (approximately 3 months) on all participants.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tamsulosin | 0/39 (0%) | 0/39 (0%) | 0/39 (0%) |
| Placebo | 0/51 (0%) | 0/51 (0%) | 1/51 (2%) |
| Event | Tamsulosin | Placebo |
|---|---|---|
| Lower Extremity EdemaGeneral disorders | 0/39 | 1/51 |
| Age, Continuous(years) | Tamsulosin | Placebo | Total |
|---|---|---|---|
| Mean | 61.04 ± 10.36 | 63.59 ± 9.91 | 62.47 ± 10.12 |
| Sex: Female, Male(Participants) | Tamsulosin | Placebo | Total |
|---|---|---|---|
| Female | 15 | 20 | 35 |
| Male | 24 | 31 | 55 |
| Ethnicity (NIH/OMB)(Participants) | Tamsulosin | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 39 | 51 | 90 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Tamsulosin | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 39 | 51 | 90 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Tamsulosin | Placebo | Total |
|---|---|---|---|
| United States | 39 | 51 | 90 |
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