Ignite Creation Date:
2024-05-06 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03632772
Status:
UNKNOWN
Last Update Posted:
2018-08-24
First Post:
2018-08-13
Brief Title:
Comparison of Solifenacin and Mirabegron in Treatment of Overactive Bladder Symptoms in Men After TURP
Sponsor:
Buddhist Tzu Chi General Hospital
Organization:
Buddhist Tzu Chi General Hospital
Study Overview
Official Title:
Comparative Study of Solifenacin and Mirabegron in Treatment of Overactive Bladder Symptoms in Men After Transurethral Resection of the Prostate - A Randomized Prospective Study
Status:
UNKNOWN
Status Verified Date:
2018-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None