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: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Buddhist Tzu Chi General Hospital
• Treatments: Mirabegron; Solifenacin Succinate

Criteria

Inclusion Criteria:

1. Male patients with BPH and undergo TURP or TUIP.

2. Patients void smoothly after catheter removal.

3. No active urinary tract infection.

4. No gross hematuria or blood clot obstruction.

5. Patient or his care giver can complete voiding diary and report symptoms.

Exclusion Criteria:

1. Patients have overt neurological diseases such as cerebrovascular disease, senile dementia or spinal cord injury.

2. Patients have severe medical disease and completely immobile.

3. Patients have PVR larger than 150ml.

4. Patients do not have OAB after TURP.