Overactive Bladder SyndromeNCT04693897
Effect of beta3-adrenoceptor Agonist on Patients With Overactive Bladder and as a Urinary Biomarker
An observational study of Overactive Bladder Syndrome and Detrusor Overactivity, run by Chang Gung Memorial Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder Syndrome, Detrusor Overactivity
- What is being tested?
- Mirabegron 50 MG and Solifenacin Succinate 5 MG
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 31 Dec 2022
- How long will I take part?
- 9 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with overactive bladder syndrome for 3 or more months with or without concurrent detrusor overactivity treated as outpatient.
Who may be able to join
- 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
Who cannot join
- Has stress urinary incontinence
- Pelvic organ prolapse
- Interstitial cystitis
- Constipation
- Gastroesophageal reflux disease
- Prior failed medical treatment for overactive bladder syndrome
Show all 10Show fewer
- Uncontrolled hypertension
- Glaucoma
- Currently pregnant
- Using other medications for overactive bladder syndrome
Trial locations and contacts
No sites are listed yet.
About this study
Official title: To Explore the Effect of beta3-adrenoceptor Agonist on Patients With Overactive Bladder and Develop Its Urinary Biomarker
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.
- Conditions
- Overactive Bladder Syndrome, Detrusor Overactivity
- Being tested
- Mirabegron 50 MG, Solifenacin Succinate 5 MG
- Keywords
- Overactive Bladder Syndrome, Mirabegron, Beta3-adrenoceptor agonist, Detrusor Overactivity, Urodynamics, Biomarker
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirabegron 50 MGDrug
Mirabegron 50mg once daily given to treatment in patients with overactive bladder syndrome
Solifenacin Succinate 5 MGDrug
Solifenacin 5mg once daily given to treatment in patients with overactive bladder syndrome
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Mirabegron 50 MG | |
| 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. Receives: Drug: Solifenacin Succinate 5 MG | |
| Urinary tract infection | Urinary samples for beta-3 adrenoceptor concentration of 100 patients with urinary tract infection. | |
| Control | Urinary samples for beta-3 adrenoceptor concentration of 100 patients without lower urinary tract symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in participant's urinary beta-3 adrenoreceptor from baseline to 12 weeks after treatment
Concentrations of urinary beta-3 adrenoceptor levels will be analyzed for 1)before and after treatment of patients with overactive bladder syndrome treated with Mirabegron; 2)before and after treatment patients with overactive bladder syndrome treated with Solifenacin; 3)patients with urinary tract infection, and 4)control (subjects without lower urinary tract symptoms).
Measured: 12 weeks
Secondary outcomes (16)
Effect of treatment with Mirabegron in patients with overactive bladder with or without detrusor overactivity after 12 weeks of treatment
Individual participant's change score on Overactive Bladder Symptom Score (OABSS) will be compared between participants treated with Mirabegron with and without detrusor overactivity after 12 weeks of treatment. The OABSS is a validated symptom questionnaire that sums the score of four symptoms (daytime frequency, nighttime frequency, urgency, and urgency incontinence). The total score ranges from 0 to 15, with higher the number, the greater the symptoms are.
Measured: 12 weeks
Effect of treatment with Mirabegron in patients with overactive bladder with or without detrusor overactivity 6 months after treatment.
Individual participant's change score on Overactive Bladder Symptom Score (OABSS) will be compared between participants treated with Mirabegron with and without detrusor overactivity 6 months after treatment. The OABSS is a validated symptom questionnaire that sums the score of four symptoms (daytime frequency, nighttime frequency, urgency, and urgency incontinence). The total score ranges from 0 to 15, with higher the number, the greater the symptoms are.
Measured: 6 months
Change in impact on the participant's life after treatment with Mirabegron with overactive bladder with or without detrusor overactivity after 12 weeks of treatment.
Individual participant's change score on the Overactive Bladder Questionnaire short-form (OAB-q SF) will be compared between participants treated with Mirabegron with and without detrusor overactivity after 12 weeks of treatment. The OAB-q SF assess the impact of OAB symptoms on the patient's life, and consists of symptom-bother and health-related quality of life. The subscales are summed and transformed into scores ranging from 0 to 100; a high symptom-bother score indicates greater symptom severity and a high health-related quality of life scale score indicates higher quality of life.
Measured: 12 weeks
Change in impact on the participant's life after treatment with Mirabegron with overactive bladder with or without detrusor overactivity 6 months after treatment
Individual participant change score on the Overactive Bladder Questionnaire short-form (OAB-q SF) will be compared between participants treated with Mirabegron with and without detrusor overactivity 6 months after treatment. The OAB-q SF assess the impact of OAB symptoms on the patient's life, and consists of symptom-bother and health-related quality of life. The subscales are summed and transformed into scores ranging from 0 to 100; a high symptom-bother score indicates greater symptom severity and a high health-related quality of life scale score indicates higher quality of life.
Measured: 6 months
Effect on the participant's life after treatment with Mirabegron with overactive bladder with or without detrusor overactivity after 12 weeks of treatment.
Individual participant's change score on Short Form Health Survey (SF-12) will be compared between participants treated with Mirabegron with and without detrusor overactivity after 12 weeks of treatment. SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. The score is converted to a range of 0 to 100, with high the score indicating a better quality of life.
Measured: 12 weeks
Effect on the participant's life after treatment with Mirabegron with overactive bladder with or without detrusor overactivity 6 months after treatment.
Individual participant's change score on Short Form Health Survey (SF-12) will be compared between participants treated with Mirabegron with and without detrusor overactivity 6 months after treatment. SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. The score is converted to a range of 0 to 100, with high the score indicating a better quality of life.
Measured: 6 months
The participant's subjective measurement of treatment outcome with Mirabegron with overactive bladder with or without detrusor overactivity after 12 weeks of treatment.
Individual participant's change score on Global Response Assessment Scale (GRAS) will be compared between participants treated with Mirabegron with and without detrusor overactivity after 12 weeks of treatment. GRAS is a subjective outcome measurement to asses the participant's perception of treatment success. The score is scaled from 0 to 100%, with greater the percentage, the greater improvement of symptoms after treatment is perceived.
Measured: 12 weeks
The participant's subjective measurement of treatment outcome with Mirabegron with overactive bladder with or without detrusor overactivity 6 months after treatment.
Individual participant's change score on Global Response Assessment Scale (GRAS) will be compared between participants treated with Mirabegron with and without detrusor overactivity 6 months after treatment. GRAS is a subjective outcome measurement to asses the participant's perception of treatment success. The score is scaled from 0 to 100%, with greater the percentage, the greater improvement of symptoms after treatment is perceived.
Measured: 6 months
Comparison of the effect of treatment with Mirabegron and Solifenacin in patients with overactive bladder after 12 weeks of treatment
Individual participant's change score on Overactive Bladder Symptom Score (OABSS) will be compared between participants treated with Mirabegron and Solifenacin in patients with overactive bladder after 12 weeks of treatment. The OABSS is a validated symptom questionnaire that sums the score of four symptoms (daytime frequency, nighttime frequency, urgency, and urgency incontinence). The total score ranges from 0 to 15, with higher the number, the greater the symptoms are.
Measured: 12 weeks
Comparison of the effect of treatment with Mirabegron and Solifenacin in patients with overactive bladder 6 months after treatment.
Individual participant's change score on Overactive Bladder Symptom Score (OABSS) will be compared between participants treated with Mirabegron and Solifenacin in patients with overactive bladder 6 months after treatment. The OABSS is a validated symptom questionnaire that sums the score of four symptoms (daytime frequency, nighttime frequency, urgency, and urgency incontinence). The total score ranges from 0 to 15, with higher the number, the greater the symptoms are.
Measured: 6 months
Comparison of the impact of symptoms on life with Mirabegron and Solifenacin in patients with overactive bladder after 12 weeks of treatment
Individual participant change score on the Overactive Bladder Questionnaire short-form (OAB-q SF) will be compared between participants treated with Mirabegron and Solifenacin in patients with overactive bladder after 12 weeks of treatment. The OAB-q SF assess the impact of OAB symptoms on the patient's life, and consists of symptom-bother and health-related quality of life. The subscales are summed and transformed into scores ranging from 0 to 100; a high symptom-bother score indicates greater symptom severity and a high health-related quality of life scale score indicates higher quality of life.
Measured: 12 weeks
Comparison of the impact of symptoms on life with Mirabegron and Solifenacin in patients with overactive bladder 6 months after treatment
Individual participant change score on the Overactive Bladder Questionnaire short-form (OAB-q SF) will be compared between participants treated with Mirabegron and Solifenacin in patients with overactive bladder 6 months after treatment. The OAB-q SF assess the impact of OAB symptoms on the patient's life, and consists of symptom-bother and health-related quality of life. The subscales are summed and transformed into scores ranging from 0 to 100; a high symptom-bother score indicates greater symptom severity and a high health-related quality of life scale score indicates higher quality of life.
Measured: 6 months
Effect on the participant's life after treatment with Mirabegron and Solifenacin after 12 weeks of treatment.
Individual participant's change score on Short Form Health Survey (SF-12) will be compared between participants treated with Mirabegron and Solifenacin after 12 weeks of treatment. SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. The score is converted to a range of 0 to 100, with high the score indicating a better quality of life.
Measured: 12 weeks
Effect on the participant's life after treatment with Mirabegron and Solifenacin 6 months after treatment.
Individual participant's change score on Short Form Health Survey (SF-12) will be compared between participants treated with Mirabegron and Solifenacin 6 months after treatment. SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. The score is converted to a range of 0 to 100, with high the score indicating a better quality of life.
Measured: 6 months
The participant's subjective measurement of treatment outcome with Mirabegron and Solifenacin after 12 weeks of treatment.
Individual participant's change score on Global Response Assessment Scale (GRAS) will be compared between participants treated with Mirabegron and Solifenacin after 12 weeks of treatment. GRAS is a subjective outcome measurement to asses the participant's perception of treatment success. The score is scaled from 0 to 100%, with greater the percentage, the greater improvement of symptoms after treatment is perceived.
Measured: 12 weeks
The participant's subjective measurement of treatment outcome with Mirabegron and Solifenacin 6 months after treatment.
Individual participant's change score on Global Response Assessment Scale (GRAS) will be compared between participants treated with Mirabegron and Solifenacin 6 months after treatment. GRAS is a subjective outcome measurement to asses the participant's perception of treatment success. The score is scaled from 0 to 100%, with greater the percentage, the greater improvement of symptoms after treatment is perceived.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Mar 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (43)Papers the sponsor has linked to this study.
- Other trials for Overactive Bladder SyndromeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ching-Chung Liang, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04693897
- Sponsor's protocol ID
- CMRPG3K2051
- Status last verified
- Jan 2021
- First submitted
- 28 Dec 2020
- Last updated
- 27 Jan 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coyne KS, Sexton CC, Kopp ZS, Ebel-Bitoun C, Milsom I, Chapple C. The impact of overactive bladder on mental health, work productivity and health-related quality of life in the UK and Sweden: results from EpiLUTS. BJU Int. 2011 Nov;108(9):1459-71. doi: 10.1111/j.1464-410X.2010.10013.x. Epub 2011 Mar 3.
PubMed 21371240Jafarabadi 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.
PubMed 25369726Milsom I, Abrams P, Cardozo L, Roberts RG, Thuroff J, Wein AJ. How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int. 2001 Jun;87(9):760-6. doi: 10.1046/j.1464-410x.2001.02228.x.
PubMed 11412210Stewart WF, Van Rooyen JB, Cundiff GW, Abrams P, Herzog AR, Corey R, Hunt TL, Wein AJ. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003 May;20(6):327-36. doi: 10.1007/s00345-002-0301-4. Epub 2002 Nov 15.
PubMed 12811491Chen GD, Lin TL, Hu SW, Chen YC, Lin LY. Prevalence and correlation of urinary incontinence and overactive bladder in Taiwanese women. Neurourol Urodyn. 2003;22(2):109-17. doi: 10.1002/nau.10010.
PubMed 12579627Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.
PubMed 11857671Hung MJ, Ho ES, Shen PS, Sun MJ, Lin AT, Chen GD; Taiwan OAB Club. Urgency is the core symptom of female overactive bladder syndrome, as demonstrated by a statistical analysis. J Urol. 2006 Aug;176(2):636-40. doi: 10.1016/j.juro.2006.03.062.
PubMed 16813910Andersson KE. Antimuscarinics for treatment of overactive bladder. Lancet Neurol. 2004 Jan;3(1):46-53. doi: 10.1016/s1474-4422(03)00622-7.
PubMed 14693111Ouslander JG. Management of overactive bladder. N Engl J Med. 2004 Feb 19;350(8):786-99. doi: 10.1056/NEJMra032662. No abstract available.
PubMed 14973214Luo D, Liu L, Han P, Wei Q, Shen H. Solifenacin for overactive bladder: a systematic review and meta-analysis. Int Urogynecol J. 2012 Aug;23(8):983-91. doi: 10.1007/s00192-011-1641-7. Epub 2012 Feb 7.
PubMed 22310924Nazir J, Kelleher C, Aballea S, Maman K, Hakimi Z, Mankowski C, Odeyemi I. Comparative efficacy and tolerability of solifenacin 5 mg/day versus other oral antimuscarinic agents in overactive bladder: A systematic literature review and network meta-analysis. Neurourol Urodyn. 2018 Mar;37(3):986-996. doi: 10.1002/nau.23413. Epub 2017 Nov 15.
PubMed 29140559Cardozo L, Thorpe A, Warner J, Sidhu M. The cost-effectiveness of solifenacin vs fesoterodine, oxybutynin immediate-release, propiverine, tolterodine extended-release and tolterodine immediate-release in the treatment of patients with overactive bladder in the UK National Health Service. BJU Int. 2010 Aug;106(4):506-14. doi: 10.1111/j.1464-410X.2009.09160.x. Epub 2010 Feb 3.
PubMed 20132203Madhuvrata P, Cody JD, Ellis G, Herbison GP, Hay-Smith EJ. Which anticholinergic drug for overactive bladder symptoms in adults. Cochrane Database Syst Rev. 2012 Jan 18;1(1):CD005429. doi: 10.1002/14651858.CD005429.pub2.
PubMed 22258963Chapple CR, Fianu-Jonsson A, Indig M, Khullar V, Rosa J, Scarpa RM, Mistry A, Wright DM, Bolodeoku J; STAR study group. Treatment outcomes in the STAR study: a subanalysis of solifenacin 5 mg and tolterodine ER 4 mg. Eur Urol. 2007 Oct;52(4):1195-203. doi: 10.1016/j.eururo.2007.05.027. Epub 2007 Jun 6.
PubMed 17574730Speakman M, Khullar V, Mundy A, Odeyemi I, Bolodeoku J. A cost-utility analysis of once daily solifenacin compared to tolterodine in the treatment of overactive bladder syndrome. Curr Med Res Opin. 2008 Aug;24(8):2173-9. doi: 10.1185/03007990802234829. Epub 2008 Jun 18.
PubMed 18565239
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore the Effect of beta3-adrenoceptor Agonist on Patients With Overactive Bladder and Develop Its Urinary Biomarker
- ClinicalTrials.gov ID
- NCT04693897
- Acronym / sponsor ID
- CMRPG3K2051
- Conditions
- Overactive Bladder Syndrome, Detrusor Overactivity
- Keywords
- Overactive Bladder Syndrome, Mirabegron, Beta3-adrenoceptor agonist, Detrusor Overactivity, Urodynamics, Biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Overactive bladder with Mirabegron | – | Drug: Mirabegron 50 MG100 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. |
| Overactive bladder with Solifenacin | – | Drug: Solifenacin Succinate 5 MG100 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. |
| Urinary tract infection | – | –Urinary samples for beta-3 adrenoceptor concentration of 100 patients with urinary tract infection. |
| Control | – | –Urinary samples for beta-3 adrenoceptor concentration of 100 patients without lower urinary tract symptoms. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with overactive bladder syndrome for 3 or more months with or without concurrent detrusor overactivity treated as outpatient.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- Has stress urinary incontinence
- Pelvic organ prolapse
- Interstitial cystitis
- Constipation
- Gastroesophageal reflux disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirabegron 50 MGMirabegron 50mg once daily given to treatment in patients with overactive bladder syndrome | Drug | Overactive bladder with Mirabegron |
| Solifenacin Succinate 5 MGSolifenacin 5mg once daily given to treatment in patients with overactive bladder syndrome | Drug | Overactive bladder with Solifenacin |
Primary outcome
Change in participant's urinary beta-3 adrenoreceptor from baseline to 12 weeks after treatment
Time frame: 12 weeks
Concentrations of urinary beta-3 adrenoceptor levels will be analyzed for 1)before and after treatment of patients with overactive bladder syndrome treated with Mirabegron; 2)before and after treatment patients with overactive bladder syndrome treated with Solifenacin; 3)patients with urinary tract infection, and 4)control (subjects without lower urinary tract symptoms).
16 secondary outcomes
Effect of treatment with Mirabegron in patients with overactive bladder with or without detrusor overactivity after 12 weeks of treatment
Time frame: 12 weeks
Effect of treatment with Mirabegron in patients with overactive bladder with or without detrusor overactivity 6 months after treatment.
Time frame: 6 months
Change in impact on the participant's life after treatment with Mirabegron with overactive bladder with or without detrusor overactivity after 12 weeks of treatment.
Time frame: 12 weeks
Change in impact on the participant's life after treatment with Mirabegron with overactive bladder with or without detrusor overactivity 6 months after treatment
Time frame: 6 months
Effect on the participant's life after treatment with Mirabegron with overactive bladder with or without detrusor overactivity after 12 weeks of treatment.
Time frame: 12 weeks
Effect on the participant's life after treatment with Mirabegron with overactive bladder with or without detrusor overactivity 6 months after treatment.
Time frame: 6 months
The participant's subjective measurement of treatment outcome with Mirabegron with overactive bladder with or without detrusor overactivity after 12 weeks of treatment.
Time frame: 12 weeks
The participant's subjective measurement of treatment outcome with Mirabegron with overactive bladder with or without detrusor overactivity 6 months after treatment.
Time frame: 6 months
Comparison of the effect of treatment with Mirabegron and Solifenacin in patients with overactive bladder after 12 weeks of treatment
Time frame: 12 weeks
Comparison of the effect of treatment with Mirabegron and Solifenacin in patients with overactive bladder 6 months after treatment.
Time frame: 6 months
Comparison of the impact of symptoms on life with Mirabegron and Solifenacin in patients with overactive bladder after 12 weeks of treatment
Time frame: 12 weeks
Comparison of the impact of symptoms on life with Mirabegron and Solifenacin in patients with overactive bladder 6 months after treatment
Time frame: 6 months
Effect on the participant's life after treatment with Mirabegron and Solifenacin after 12 weeks of treatment.
Time frame: 12 weeks
Effect on the participant's life after treatment with Mirabegron and Solifenacin 6 months after treatment.
Time frame: 6 months
The participant's subjective measurement of treatment outcome with Mirabegron and Solifenacin after 12 weeks of treatment.
Time frame: 12 weeks
The participant's subjective measurement of treatment outcome with Mirabegron and Solifenacin 6 months after treatment.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Results publication: PubMed 21371240Coyne KS, Sexton CC, Kopp ZS, Ebel-Bitoun C, Milsom I, Chapple C. The impact of overactive bladder on mental health, work productivity and health-related quality of life in the UK and Sweden: results from EpiLUTS. BJU Int. 2011 Nov;108(9):1459-71. doi: 10.1111/j.1464-410X.2010.10013.x. Epub 2011 Mar 3.
- Results publication: PubMed 25369726Jafarabadi 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.
- Results publication: PubMed 11412210Milsom I, Abrams P, Cardozo L, Roberts RG, Thuroff J, Wein AJ. How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int. 2001 Jun;87(9):760-6. doi: 10.1046/j.1464-410x.2001.02228.x.
- Results publication: PubMed 12811491Stewart WF, Van Rooyen JB, Cundiff GW, Abrams P, Herzog AR, Corey R, Hunt TL, Wein AJ. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003 May;20(6):327-36. doi: 10.1007/s00345-002-0301-4. Epub 2002 Nov 15.
- Results publication: PubMed 12579627Chen GD, Lin TL, Hu SW, Chen YC, Lin LY. Prevalence and correlation of urinary incontinence and overactive bladder in Taiwanese women. Neurourol Urodyn. 2003;22(2):109-17. doi: 10.1002/nau.10010.
- Results publication: PubMed 11857671Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.
- Results publication: PubMed 16813910Hung MJ, Ho ES, Shen PS, Sun MJ, Lin AT, Chen GD; Taiwan OAB Club. Urgency is the core symptom of female overactive bladder syndrome, as demonstrated by a statistical analysis. J Urol. 2006 Aug;176(2):636-40. doi: 10.1016/j.juro.2006.03.062.
- Results publication: PubMed 14693111Andersson KE. Antimuscarinics for treatment of overactive bladder. Lancet Neurol. 2004 Jan;3(1):46-53. doi: 10.1016/s1474-4422(03)00622-7.
- Results publication: PubMed 14973214Ouslander JG. Management of overactive bladder. N Engl J Med. 2004 Feb 19;350(8):786-99. doi: 10.1056/NEJMra032662. No abstract available.
- Results publication: PubMed 22310924Luo D, Liu L, Han P, Wei Q, Shen H. Solifenacin for overactive bladder: a systematic review and meta-analysis. Int Urogynecol J. 2012 Aug;23(8):983-91. doi: 10.1007/s00192-011-1641-7. Epub 2012 Feb 7.
- Results publication: PubMed 29140559Nazir J, Kelleher C, Aballea S, Maman K, Hakimi Z, Mankowski C, Odeyemi I. Comparative efficacy and tolerability of solifenacin 5 mg/day versus other oral antimuscarinic agents in overactive bladder: A systematic literature review and network meta-analysis. Neurourol Urodyn. 2018 Mar;37(3):986-996. doi: 10.1002/nau.23413. Epub 2017 Nov 15.
- Results publication: PubMed 20132203Cardozo L, Thorpe A, Warner J, Sidhu M. The cost-effectiveness of solifenacin vs fesoterodine, oxybutynin immediate-release, propiverine, tolterodine extended-release and tolterodine immediate-release in the treatment of patients with overactive bladder in the UK National Health Service. BJU Int. 2010 Aug;106(4):506-14. doi: 10.1111/j.1464-410X.2009.09160.x. Epub 2010 Feb 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder Syndrome and Detrusor Overactivity, run by Chang Gung Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ching-Chung Liang, MD (+886-3-3281200 ext. 8258, ccjoliang@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in participant's urinary beta-3 adrenoreceptor from baseline to 12 weeks after treatment (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04693897, which also lists 43 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.