Comparison of Solifenacin and Mirabegron in Treatment of Overactive Bladder Symptoms in Men After TURP
NCT ID: NCT03632772
Last Updated: 2018-08-24
Study Results
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Basic Information
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UNKNOWN
PHASE2
130 participants
INTERVENTIONAL
2018-08-01
2019-07-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Solifenacin 5 mg for 4 weeks
Solifenacin 5 mg once-daily for 4 weeks.
Solifenacin 5Mg
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.
Mirabegron 50 mg for 4 weeks
Mirabegron 50 mg once-daily for 4 weeks.
Mirabegron 50 MG
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.
Control: non treatment
Control: non treatment.
No interventions assigned to this group
Interventions
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Solifenacin 5Mg
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.
Mirabegron 50 MG
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. Patients have severe medical disease and completely immobile.
3. Patients have PVR larger than 150ml.
4. Patients do not have OAB after TURP.
20 Years
80 Years
MALE
No
Sponsors
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Buddhist Tzu Chi General Hospital
OTHER
Responsible Party
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Hann-Chorng Kuo
Chairman and Professor, Department of Urology
Principal Investigators
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Hann-Chorng Kuo, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Urology, Buddhist Tzu Chi General Hospital, Hualien
Locations
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Buddhist Tzu Chi General Hospital
Hualien City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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Seki N, Yuki K, Takei M, Yamaguchi A, Naito S. Analysis of the prognostic factors for overactive bladder symptoms following surgical treatment in patients with benign prostatic obstruction. Neurourol Urodyn. 2009;28(3):197-201. doi: 10.1002/nau.20619.
Yamada S, Ito Y, Nishijima S, Kadekawa K, Sugaya K. Basic and clinical aspects of antimuscarinic agents used to treat overactive bladder. Pharmacol Ther. 2018 Sep;189:130-148. doi: 10.1016/j.pharmthera.2018.04.010. Epub 2018 Apr 27.
Kelleher C, Hakimi Z, Zur R, Siddiqui E, Maman K, Aballea S, Nazir J, Chapple C. Efficacy and Tolerability of Mirabegron Compared with Antimuscarinic Monotherapy or Combination Therapies for Overactive Bladder: A Systematic Review and Network Meta-analysis. Eur Urol. 2018 Sep;74(3):324-333. doi: 10.1016/j.eururo.2018.03.020. Epub 2018 Apr 23.
Wada N, Iuchi H, Kita M, Hashizume K, Matsumoto S, Kakizaki H. Urodynamic Efficacy and Safety of Mirabegron Add-on Treatment with Tamsulosin for Japanese Male Patients with Overactive Bladder. Low Urin Tract Symptoms. 2016 Sep;8(3):171-6. doi: 10.1111/luts.12091. Epub 2015 Feb 17.
Nitti VW, Rosenberg S, Mitcheson DH, He W, Fakhoury A, Martin NE. Urodynamics and safety of the beta(3)-adrenoceptor agonist mirabegron in males with lower urinary tract symptoms and bladder outlet obstruction. J Urol. 2013 Oct;190(4):1320-7. doi: 10.1016/j.juro.2013.05.062. Epub 2013 May 30.
Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
Other Identifiers
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TCGH107-115-A
Identifier Type: -
Identifier Source: org_study_id
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