A Phase 2 interventional study of Solifenacin 5Mg and Mirabegron 50 MG in Overactive Bladder Syndrome, sponsored by Buddhist Tzu Chi General Hospital. Status unknown at 1 site in Taiwan. Open to male participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-08-24.
Sponsored by Buddhist Tzu Chi General Hospital · Phase 2, Interventional, and Treatment
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.
Introduction:
Urinary frequency urgency and urgency urinary incontinence (UUI) are commonly encountered in patients after transurethral prostatectomy (TURP) or transurethral incision of the prostate (TUIP). [1] Patients usually bother by these overactive bladder (OAB) symptoms. The causes of postprostatectomy OAB might be detrusor overactivity (DO) before TURP, increase afferent input due to acute inflammation after TURP, or a weak urethral sphincter which cannot hold urine at the bladder capacity. Antimuscarinics and beta-3 adrenoceptor agonist are two different classes of medication for OAB. [2] 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. [3] However, antimuscarnics might decrease detrusor contractility and result in increase of postvoid residual (PVR) volume. Current clinical studies reveal that mirabegron does not impair detrusor contractility or increase PVR. [4] Under this consideration, mirabegron has been widely used to treat male lower urinary tract symptoms (LUTS) due to benign prostate hyperplasia (BPH). [5] 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.
Material and methods:
Objectives and Endpoints: 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.
Randomization: Permuted block randomization method will be applied to generate randomization codes. Each randomization number will be assigned to individual patient according to the time-sequence for screened patient become eligible.
Expected Results:
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.
855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.
This study's planned enrollment of 130 is above the median of 72 across 652 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Buddhist Tzu Chi General Hospital is the lead sponsor of 84 studies on the registry; 21 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Solifenacin 5 mg once-daily for 4 weeks.
Drug: Solifenacin 5Mg
Mirabegron 50 mg once-daily for 4 weeks.
Drug: Mirabegron 50 MG
Control: non treatment.
We compared the safety and therapeutic efficacy between Solifenacin and Mirabegron in men with benign prostate hyperplasia and having overactive bladder symptoms immediately after Transurethral Resection of the Prostate.
Also known as: Vesicare
We compared the safety and therapeutic efficacy between Solifenacin and Mirabegron in men with benign prostate hyperplasia and having overactive bladder symptoms immediately after Transurethral Resection of the Prostate.
Also known as: Betmiga
Urgency Severity Scale (USS)
The change of USS from baseline to 4 weeks after catheter removal and starting OAB medication.
Time frame: from baseline to 4 weeks
Overactive Bladder Symptom Score (OABSS)
The changes of OABSS
Time frame: from baseline to 2 weeks and 4 weeks.
frequency episodes, urgency episodes, urgency urinary incontinence (UUI) episodes in the 3-day voiding diary
The changes of frequency episodes, urgency episodes, urgency urinary incontinence (UUI) episodes in the 3-day voiding diary
Time frame: from baseline to 2 weeks and 4 weeks.
maximum flow rate (Qmax)
The changes of maximum flow rate (Qmax)
Time frame: from baseline to 2 weeks and 4 weeks.
voided volume (Vol)
The changes of voided volume (Vol)
Time frame: from baseline to 2 weeks and 4 weeks.
Postvoid residual volume (PVR)
The changes of Postvoid residual volume (PVR)
Time frame: from baseline to 2 weeks and 4 weeks.
International Prostate Symptom Score (IPSS)
The changes of International Prostate Symptom Score (IPSS)
Time frame: from baseline to 2 weeks and 4 weeks.
quality of life index (QoL-I)
The changes of quality of life index (QoL-I)
Time frame: from baseline to 2 weeks and 4 weeks.
Plan to share: No — IPD was not planned to share.
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Buddhist Tzu Chi General Hospital