Comparison of Solifenacin and Mirabegron in Treatment of Overactive Bladder Symptoms in Men After TURP
Status:
Unknown status
Trial end date:
2019-07-31
Target enrollment:
Participant gender:
Summary
Urinary frequency urgency and urgency urinary incontinence (UUI) are commonly encountered in
patients after transurethral prostatectomy (TURP) or transurethral incision of the prostate
(TUIP). Antimuscarinics has been widely used to treat OAB and around 70% of patients can
improve symptoms after treatment. Beta-3 adrenoceptor agonist (mirabegron) can also decrease
DO and improve OAB symptoms. Combination treatment of solifenacin 5mg plus mirabegron 25 or
50mg was more effective than mirabegron 50mg alone, but with more anticholinergic side
effects. However, there has been no clinical trial to compare which drug provides more
benefit to decrease the OAB symptom severity immediately after TURP. This study tries to
compare the safety and therapeutic efficacy between solifenacin and mirabegron in men with
BPH and having OAB symptoms immediately after TURP.
This study was designed as a prospective, randomized trial to compare the safety and efficacy
of OAB medication on the decrease of overactive bladder symptoms score (OABSS) and urgency
severity score (USS) between solifenacin 5mg QD and mirabegron 50mg QD in men with BPH
undergoing TURP. A total of 130 male patients with BPH and undergo TURP or TUIP will be
enrolled. The primary end point is the change of USS from baseline to 4 weeks after catheter
removal and starting OAB medication. Secondary end-points include the changes of OABSS,
frequency episodes, urgency episodes, UUI episodes in the 3-day voiding diary, maximum flow
rate (Qmax), voided volume and PVR, International Prostate Symptom Score (IPSS) and quality
of life index (QoL-I) from baseline to 2 weeks and 4 weeks.
We expect that patients receiving solifenacin and mirabegron might have similar therapeutic
effects on decrease of USS, but patients who received mirabegron might have less adverse
events such as dry mouth or difficulty in urination.