Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tamsulosin · 1 trial · 1 indication
Self-reported void within 6-8 hours post operative
Time (number of minutes) to first postoperative spontaneous urination post operation
Volume of urine during the first postoperative spontaneous urination post operation.
Patients will receive a bladder scan post their first postoperative spontaneous urination and the amount of residual urine will be measured.
Patients that did not spontaneously urinate within 6-8 hours post operative will have an intervention. Potential interventions include : a) Prompted voiding and rescanning in 2 hours; b) Intermittent catheterization and patient prompting; c) Indwelling catheter inserted.
| Arm | Type | Description |
|---|---|---|
| Pre-operative Tamsulosin administration | EXPERIMENTAL | Subjects will be provided with a prescription for Tamsulosin (generic) to be taken 7 days prior to scheduled surgery for thoracic cancer. Tamsulosin dose is set at 0.4mg/day and should be taken daily for seven days prior to their planned surgery date. Study subjects will also be given a diary to record their daily usage. Study subjects should take Tamsulosin on the day of the surgery with a sip of water. |
| Name | Type | Description |
|---|---|---|
| Tamsulosin | DRUG | Tamsulosin 0.4 mg one time daily after a meal for seven days prior to surgery. Post-surgery, an ultrasound of the bladder will be completed approximately six hours after surgery to assess the bladder. If the bladder ultrasound shows more than 400 cc of urine in the bladder, or if the study subject passes urine on his own and there is more than 100cc or less than 400 cc of urine left in the bladder, he will be encouraged to try to pass urine. Study subject will be monitored for two additional hours. If a study subject is unable to pass urine at this time or the bladder has 400 cc or more of urine left in it, he will have an intermittent catheter (in and out) to drain urine. If the bladder has greater than 500 cc (which is approximately 16 and two-thirds ounces) per catheterization for more than 24 hours, and the study subject cannot pass urine, an indwelling catheter may be considered. |
Inclusion Criteria: * Males * ≥55 years old * Planned thoracic oncological surgical procedure of a video assisted oncological surgical procedure for suspected or confirmed cancer. * Surgery scheduled more than 7 days from the time of consent Exclusion Criteria: * Using Tamsulosin already * Known ...
Tamsulosin is being studied for the treatment of urinary retention, specifically post operative urinary retention following thoracic oncological surgery. It is currently in early Phase 1 clinical development as an investigational small molecule therapy for this condition.
Tamsulosin is being developed by Meridian Bioscience Inc, a company traded on the stock exchange under the ticker VIVO. The company is conducting clinical research to evaluate the drug's potential in treating urinary retention.
Tamsulosin is in early Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and efficacy for urinary retention.
Tamsulosin is being evaluated in a clinical trial with the identifier NCT05657990, titled 'Post Operative Urinary Retention (POUR) Following Thoracic Oncological Surgery'. This trial is currently recruiting participants in the United States and is expected to enroll 46 male patients aged 55 years and older.
Tamsulosin is the generic name for the medication also known as tamsulosin hydrochloride. In the context of this clinical development program, the drug is referred to as Tamsulosin, and it is being investigated for its potential role in managing urinary retention.