This phase 3 trial is examining the effectiveness of vibegron in the treatment of overactive bladder symptoms (OAB) in patients with prostatic hyperplasia (BPH; enlarged prostatic gland). The main outcome of this trial will be a change in urgency episodes. This trial is being conducted in the US and Canada.
A benign (not cancerous) prostatic hyperplasia is a common, but treatable condition in older men. Patients with this condition have an overgrowth of the prostatic gland. This pushes against the bladder causing urinary symptoms.
The bladder is the organ that stores and releases urine. When full, it contracts, causing an urge to urinate. In patients with OAB, the bladder contracts even when its empty or with small amounts of urine. The effectiveness of vibegron in the treatment of OAB is not fully known.
This trial is examining the effectiveness of vibegron in the treatment of OAB symptoms in patients with BPH. The main outcome will be a change in urgency episodes.
Who are they looking for?
This trial will be recruiting 1088 participants with BPH and OAB. These patients must have a prostate-specific antigen (PSA; a blood marker for prostate cancer and other prostate abnormalities) between 4 and 10 ng/mL or lower than 4 ng/mL. Patients must urinate between 8 and 20 times per day and at least 2 times during the night. Must have more than 3 urgency episodes a day and a remaining urine volume of less than 100mL.
Participants must not have a history of 24-hour urine volume greater than 3L. Patients must not have another urinary disorder, urine retention, urinary infection or any severe heart condition, or a history of prostate surgery. Uncontrolled high blood pressure, diabetes, kidney, or liver disease are other exclusion criteria.
How will it work
Patients will be assigned to receive oral vibegron (75 mg) once daily for 24 weeks or placebo (a drug with no effect on the body). Patients will be assessed at day 0 and at 12 weeks for the number of times the patient urinates in a day.