Effect of beta3-adrenoceptor Agonist on Patients With Overactive Bladder and as a Urinary Biomarker
NCT ID: NCT04693897
Last Updated: 2021-01-27
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
400 participants
Study Classification
OBSERVATIONAL
Study Start Date
2021-03-01
Study Completion Date
2022-12-31
Brief Summary
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About one to two million women in Taiwan suffers from overactive bladder (OAB). The most commonly used anti-muscarinic drugs have a high rate of side effects. While beta-3 adrenoceptor agonist, Mirabegron, has far fewer side effects, there are no consensus on whether it can be used as first-line treatment. The investigator's preliminary study showed that the concentration of beta-3 adrenoceptor in the urine of OAB patients is higher than that in the normal control group, so comparing urinary beta-3 adrenoceptor concentration of OAB patients before and after treatment may be used as a biomarker of therapeutic effectiveness. The results of this study will be of great help in understanding the effectiveness of Mirabegron and formulating OAB treatment plans.
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Detailed Description
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Conditions
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Overactive Bladder Syndrome
Detrusor Overactivity
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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Overactive bladder with Mirabegron
100 patients with overactive bladder syndrome, diagnosed according to 2002 ICS diagnosis will undergo 12 weeks of Mirabegron 50mg once daily use. Evaluation include questionnaire survey and urine beta-3 adrenoceptor concentration.
Mirabegron 50 MG
Intervention Type
DRUG
Mirabegron 50mg once daily given to treatment in patients with overactive bladder syndrome
Overactive bladder with Solifenacin
100 patients with overactive bladder syndrome, diagnosed according to 2002 ICS diagnosis will undergo 12 weeks of Solifenacin 5mg once daily use. Evaluation include questionnaire survey and urine beta-3 adrenoceptor concentration.
Solifenacin Succinate 5 MG
Intervention Type
DRUG
Solifenacin 5mg once daily given to treatment in patients with overactive bladder syndrome
Urinary tract infection
Urinary samples for beta-3 adrenoceptor concentration of 100 patients with urinary tract infection.
No interventions assigned to this group
Control
Urinary samples for beta-3 adrenoceptor concentration of 100 patients without lower urinary tract symptoms.
No interventions assigned to this group
Interventions
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Mirabegron 50 MG
Mirabegron 50mg once daily given to treatment in patients with overactive bladder syndrome
Intervention Type
DRUG
Solifenacin Succinate 5 MG
Solifenacin 5mg once daily given to treatment in patients with overactive bladder syndrome
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Diagnosis compatible with 2002 ICS for overactive bladder syndrome
* Symptoms persisted for more than 3 months
* Completed pre-treatment urodynamic study
* Has plans for treatment with Mirabegron or Solifenacin due to clinical symptoms
* Patient is willing to cooperate with study including follow up and complete questionnaire surveys
* Symptoms persisted for more than 3 months
* Completed pre-treatment urodynamic study
* Has plans for treatment with Mirabegron or Solifenacin due to clinical symptoms
* Patient is willing to cooperate with study including follow up and complete questionnaire surveys
Exclusion Criteria
* Has stress urinary incontinence
* Pelvic organ prolapse
* Interstitial cystitis
* Constipation
* Gastroesophageal reflux disease
* Prior failed medical treatment for overactive bladder syndrome
* Uncontrolled hypertension
* Glaucoma
* Currently pregnant
* Using other medications for overactive bladder syndrome
* Pelvic organ prolapse
* Interstitial cystitis
* Constipation
* Gastroesophageal reflux disease
* Prior failed medical treatment for overactive bladder syndrome
* Uncontrolled hypertension
* Glaucoma
* Currently pregnant
* Using other medications for overactive bladder syndrome
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
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Chang Gung Memorial Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Ching-Chung Liang
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Central Contacts
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References
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Liu HT, Chancellor MB, Kuo HC. Decrease of urinary nerve growth factor levels after antimuscarinic therapy in patients with overactive bladder. BJU Int. 2009 Jun;103(12):1668-72. doi: 10.1111/j.1464-410X.2009.08380.x. Epub 2009 Feb 11.
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Ciftci S, Ozkurkcugil C, Yilmaz H, Ustuner M, Yavuz U, Yuksekkaya M, Cekmen MB. Urinary nerve growth factor and a variable solifenacin dosage in patients with an overactive bladder. Int Urogynecol J. 2016 Feb;27(2):275-80. doi: 10.1007/s00192-015-2825-3. Epub 2015 Aug 27.
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Hashim H, Abrams P. Is the bladder a reliable witness for predicting detrusor overactivity? J Urol. 2006 Jan;175(1):191-4; discussion 194-5. doi: 10.1016/S0022-5347(05)00067-4.
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Giarenis I, Mastoroudes H, Srikrishna S, Robinson D, Cardozo L. Is there a difference between women with or without detrusor overactivity complaining of symptoms of overactive bladder? BJU Int. 2013 Aug;112(4):501-7. doi: 10.1111/j.1464-410X.2012.11652.x. Epub 2013 Mar 4.
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Diamond P, Hassonah S, Alarab M, Lovatsis D, Drutz HP. The prevalence of detrusor overactivity amongst patients with symptoms of overactive bladder: a retrospective cohort study. Int Urogynecol J. 2012 Nov;23(11):1577-80. doi: 10.1007/s00192-012-1781-4. Epub 2012 Apr 25.
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Jeong SJ, Lee SC, Jeong CW, Hong SK, Byun SS, Lee SE. Clinical and urodynamic differences among women with overactive bladder according to the presence of detrusor overactivity. Int Urogynecol J. 2013 Feb;24(2):255-61. doi: 10.1007/s00192-012-1817-9. Epub 2012 May 16.
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Malone-Lee JG, Al-Buheissi S. Does urodynamic verification of overactive bladder determine treatment success? Results from a randomized placebo-controlled study. BJU Int. 2009 Apr;103(7):931-7. doi: 10.1111/j.1464-410X.2009.08361.x. Epub 2009 Mar 5.
Reference Type
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Nitti VW, Rovner ES, Bavendam T. Response to fesoterodine in patients with an overactive bladder and urgency urinary incontinence is independent of the urodynamic finding of detrusor overactivity. BJU Int. 2010 May;105(9):1268-75. doi: 10.1111/j.1464-410X.2009.09037.x. Epub 2009 Nov 4.
Reference Type
RESULT
Kuo HC, Lee KS, Na Y, Sood R, Nakaji S, Kubota Y, Kuroishi K. Results of a randomized, double-blind, parallel-group, placebo- and active-controlled, multicenter study of mirabegron, a beta3-adrenoceptor agonist, in patients with overactive bladder in Asia. Neurourol Urodyn. 2015 Sep;34(7):685-92. doi: 10.1002/nau.22645. Epub 2014 Aug 17.
Reference Type
RESULT
Hsiao SM, Chang TC, Wu WY, Chen CH, Yu HJ, Lin HH. Comparisons of urodynamic effects, therapeutic efficacy and safety of solifenacin versus tolterodine for female overactive bladder syndrome. J Obstet Gynaecol Res. 2011 Aug;37(8):1084-91. doi: 10.1111/j.1447-0756.2010.01493.x. Epub 2011 Apr 19.
Reference Type
RESULT
Sheng W, Zhang H, Ruth KH. Could urinary nerve growth factor be a biomarker for overactive bladder? A meta-analysis. Neurourol Urodyn. 2017 Sep;36(7):1703-1710. doi: 10.1002/nau.23210. Epub 2017 Jan 19.
Reference Type
RESULT
Steers WD, Kolbeck S, Creedon D, Tuttle JB. Nerve growth factor in the urinary bladder of the adult regulates neuronal form and function. J Clin Invest. 1991 Nov;88(5):1709-15. doi: 10.1172/JCI115488.
Reference Type
RESULT
Clemow DB, Steers WD, Tuttle JB. Stretch-activated signaling of nerve growth factor secretion in bladder and vascular smooth muscle cells from hypertensive and hyperactive rats. J Cell Physiol. 2000 Jun;183(3):289-300. doi: 10.1002/(SICI)1097-4652(200006)183:33.0.CO;2-6.
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RESULT
Liu HT, Kuo HC. Urinary nerve growth factor level could be a potential biomarker for diagnosis of overactive bladder. J Urol. 2008 Jun;179(6):2270-4. doi: 10.1016/j.juro.2008.01.146. Epub 2008 Apr 18.
Reference Type
RESULT
Liu HT, Kuo HC. Urinary nerve growth factor levels are elevated in patients with overactive bladder and do not significantly increase with bladder distention. Neurourol Urodyn. 2009;28(1):78-81. doi: 10.1002/nau.20599.
Reference Type
RESULT
Mukerji G, Yiangou Y, Grogono J, Underwood J, Agarwal SK, Khullar V, Anand P. Localization of M2 and M3 muscarinic receptors in human bladder disorders and their clinical correlations. J Urol. 2006 Jul;176(1):367-73. doi: 10.1016/S0022-5347(06)00563-5.
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RESULT
Jafarabadi M, Jafarabadi L, Shariat M, Rabie Salehi G, Haghollahi F, Rashidi BH. Considering the prominent complaint as a guide in medical therapy for overactive bladder syndrome in women over 45 years. J Obstet Gynaecol Res. 2015 Jan;41(1):120-6. doi: 10.1111/jog.12483. Epub 2014 Nov 5.
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RESULT
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RESULT
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Reference Type
RESULT
Other Identifiers
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CMRPG3K2051
Identifier Type: -
Identifier Source: org_study_id
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