Urinary Bladder, OveractiveNCT04420533
Comparative Study Between Behavior Therapy and Behavior Therapy Plus Mirabegron in Sexually Active Men With OAB Symptoms
A study testing Behavior therapy alone and Mirabegron 50 MG Extended Release Oral Tablet in people with Urinary Bladder, Overactive and Sexual Behavior, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The objective of this study is to evaluate and compare the therapeutic effects on OAB symptoms, and sexual functions, in terms of erectile function and ejaculatory function, in sexually active OAB male treated with behavior therapy or behavior therapy plus Mirabegron (50 mg). Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Urinary Bladder, Overactive, Sexual Behavior, Sexual Activity
- What is being tested?
- Behavior therapy alone and Mirabegron 50 MG Extended Release Oral Tablet
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Jun 2020to 31 Aug 2022
- Phase
- Interventional
- 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 20 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sexually active men with OAB ≥ 20 years
- Diagnosed with OAB based on OABSS (OABSS urgency score of ≥2 and sum score of ≥3)
- Patients can sign informed consent and record voiding diary
Who cannot join
- Concurrent use of PDE5 inhibitor or testosterone therapy during study period
- History of stress urinary incontinence
- Neurologic conditions associated with OAB symptoms
- Evidence of active urinary tract infection or urinary tract stone at screening
- Confirmed or suspected genitourinary tract or pelvic malignancy
- Genitourinary tract operation during the 3-month period prior to baseline
Show all 11Show fewer
- Postvoid residual urine volume (PVR) ≥ 100 mL
- History of uncontrolled hypertension (systolic >180 mmHg and/or diastolic >110 mmHg)
- History of intolerance to mirabegron
- History of medical conditions or presence of patient factors that, in the judgement of the investigator, would preclude adherence to study protocol
- Patient had received intravesical onabotulinumoxinA treatment within recent 6 months
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Chang Gung Memorial Hospital, Chang Gung University College of Medicine
Kaohsiung City, 833
About this study
Official title: Comparative Study Between Behavior Therapy and Behavior Therapy Plus Mirabegron 50mg in Sexually Active Men With Bothersome Overactive Bladder Symptoms - A Multicenter, Randomized Study
The objective of this study is to evaluate and compare the therapeutic effects on OAB symptoms, and sexual functions, in terms of erectile function and ejaculatory function, in sexually active OAB male treated with behavior therapy or behavior therapy plus Mirabegron (50 mg).
Read the detailed description
Overactive bladder (OAB) syndrome is a subset of storage-predominant lower urinary tract symptoms (LUTS) and has a significant impact on quality of life. Men with OAB generally experience a reduced quality of life, which may include a negative impact on sexual function. A previous study revealed that OAB is associated with erectile dysfunction (ED; prevalence odds ratio, 1.5; 95% confidence interval, 1.1-2.2) to a level comparable with that of hypertension or diabetes, both of which are known risk factors for ED. Furthermore, men with OAB were nine and seven times more likely to report diminished sexual enjoyment and decreased sexual activity, respectively, due to urinary symptoms than men without urinary symptoms.
Behavior therapies are designed as first- line treatment for the treatment of OAB with or without concomitant medication. Mirabegron, a selective β3 adrenoceptor agonist, is indicated for the treatment of OAB. Earlier research studying the role and distribution of β3-adrenoreceptors revealed that the receptors exert other physiological functions such as lipolysis and are present not only in adipose tissue but also in human gall bladder, colon, prostate, skeletal muscles and corpus cavernosum (CC) smooth muscles. It was found that activation by a selective experimental β3-receptor agonist, BRL 37344, elicited relaxation of human CC smooth muscle via a cGMP-dependent but NO-independent mechanism, leading to observable β3-receptor-mediated vasorelaxant tone of CC. The potential effect of β3-receptor agonism at human CC mediated by highly selective mirabegron in both human CC and rat CC that mirabegron markedly relaxed isolated CC strips by activating β3-adrenoceptors localized in cavernosal smooth muscle cells, independently of the NO-cGMP pathway. Recently, intra-cavernosal injection of mirabegron improved erectile function and neurogenic relaxation of corpus cavernosum in diabetic rats.
These early results have spurred research interest in mirabegron-induced CC relaxation and encouraged further clinical studies observing and evaluating the effect of mirabegron on male sexual function. Researchers at Johns Hopkins University has recently completed recruitment of a phase 1 interventional trial (NCT02916693) that aimed to address the hypothesis that activation of β3-adrenoceptors by mirabegron offers an alternative pharmacologic pathway for the treatment of erectile dysfunction. A preliminary small-scale prospective interventional study including 128 male LUTS patients treated with mirabegron 50 mg, 34 of whom had diagnosis of OAB and were sexually active, showed that mirabegron usage did not improve erectile function, as evaluated by International Index of Erectile Function (IIEF-5 4.9% decrease at 4-week; p = 0.106, and 9.1% decrease at 12-week follow-up; p = 0.077). However, the IIEF-5 was significantly decreased in the higher baseline IIEF-5 (≥17) group (11.7% decrease; p = 0.044), noncoronary artery disease (13.2%; p = 0.007) group and non-DM group (13.9% decrease; p = 0.021) at 12-week follow-up.
The accumulated research output warrants the initiation of a prospective study involving a larger patient cohort to evaluate the effect of mirabegron on male sexual function in addition to alleviate OAB symptoms. The objective of this study is to evaluate and compare the therapeutic effects on OAB symptoms, and sexual functions, in terms of erectile function and ejaculatory function, in sexually active OAB male treated with behavior therapy or behavior therapy plus Mirabegron (50 mg).
- Conditions
- Urinary Bladder, Overactive, Sexual Behavior, Sexual Activity, Behavior Therapy, Sexual Function Disturbances
- Being tested
- Behavior therapy alone, Mirabegron 50 MG Extended Release Oral Tablet
- Keywords
- overactive bladder, mirabegron 50mg
- Medical subject headings
- Urinary Bladder, Overactive, Sexual Behavior, Sexual Dysfunctions, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior therapy aloneBehavioural
- reduction of fluid intake at specific times aimed at reducing urinary frequency when most inconvenient;
- moderation of intake of caffeine or alcohol, which may have a diuretic and irritant effect, thereby increasing fluid output and enhancing frequency, urgency and nocturia;
- use of relaxed and double-voiding techniques;
- urethral milking to prevent post-micturition dribble;
- distraction techniques such as penile squeeze, breathing exercises, perineal pressure, and mental tricks to take the mind off the bladder and toilet, to help control storage symptoms;
- bladder retraining that encourages men to hold on when they have sensory urgency;
- reviewing the medication and optimising the time of administration or substituting drugs for others that have fewer urinary effects (these recommendations apply especially to diuretics);
- providing necessary assistance when there is impairment of dexterity, mobility or mental state;
- treatment of constipation.
Mirabegron 50 MG Extended Release Oral TabletDrug
Also called Mirabegron 50 MG
Betmiga prolonged-release tablets (mirabegron) 50mg QDAC PO
| Study group | Role | What they receive |
|---|---|---|
| Behavior therapy alone | Active comparator | Behavior therapy alone Receives: Behavioral: Behavior therapy alone |
| Behavior therapy plus mirabegron 50mg | Experimental | Behavior therapy plus Betmiga prolonged-release tablets (mirabegron) 50mg QDAC PO Receives: Behavioral: Behavior therapy alone; Drug: Mirabegron 50 MG Extended Release Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in OABSS at Week 12
Change from baseline in OABSS (Overactive Bladder Symptom Score) at Week 12 (lower OABSS score represent a better outcome)
Measured: Baseline and Week 12
Change from baseline in IIEF-5 at Week 12
Change from baseline in IIEF-5 (International Index of Erectile Function) at Week 12 (higher IIEF-5 score represent a better outcome)
Measured: Baseline and Week 12
Secondary outcomes (11)
Change from baseline in OABSS at Week 4
Change from baseline in OABSS (Overactive Bladder Symptom Score) at Week 12 (lower OABSS score represent a better outcome)
Measured: Baseline and Week 4
Change from baseline in IIEF-5 at Week 4
Change from baseline in IIEF-5 (International Index of Erectile Function) at Week 12 (higher IIEF-5 score represent a better outcome)
Measured: Baseline and Week 4
Change from baseline in MSHQ-EjD Short Form score at Week 4
Change from baseline in MSHQ-EjD (Male Sexual Health Questionnaire -Ejaculatory Domain) Short Form score at Week 4 (higher MSHQ-EjD Short Form Q1-Q3 sum scores represent a better outcome; lowerer MSHQ-EjD Short Form Q4 score represent a better outcome)
Measured: Baseline and Week 4
Change from baseline in MSHQ-EjD Short Form score at Week 12
Change from baseline in MSHQ-EjD (Male Sexual Health Questionnaire -Ejaculatory Domain) Short Form score at Week 12 (higher MSHQ-EjD Short Form Q1-Q3 sum scores represent a better outcome; lower MSHQ-EjD Short Form Q4 score represent a better outcome)
Measured: Baseline and Week 12
Net change of Frequency episode, nocturia episode, urgency episode, UUI episodes in 3-day voiding diary from baseline to 1 and 3 months after the treatment day
Net change of Frequency episode, nocturia episode, urgency episode, UUI episodes in 3-day voiding diary from baseline to 1 and 3 months after the treatment day (lower episode represent a better outcome)
Measured: Baseline, Week 4 and Week 12
Net change of Qmax from baseline to 1 and 3 months after the treatment day
Net change of maximum flow rate (Qmax) from baseline to 1 and 3 months after the treatment day (higher Qmax and voided volume represent a better outcome)
Measured: Baseline, Week 4 and Week 12
Net change of voided volume from baseline to 1 and 3 months after the treatment day
Net change of voided volume from baseline to 1 and 3 months after the treatment day (higher voided volume represent a better outcome)
Measured: Baseline, Week 4 and Week 12
Net change of PVR volume from baseline to 1 and 3 months after the treatment day
Net change of postvoid residual (PVR) volume from baseline to 1 and 3 months after the treatment day (lower PVR represent a better outcome)
Measured: Baseline, Week 4 and Week 12
Net change of IPSS from baseline to 1 and 3 months after the treatment day
Net change of IPSS (International prostate symptom score) from baseline to 1 and 3 months after the treatment day (lower IPSS represent a better outcome)
Measured: Baseline, Week 4 and Week 12
Net change of PPBC score from baseline to 1 and 3 months after the treatment day
Net change of PPBC score (Patient perception of bladder condition) from baseline to 1 and 3 months after the treatment day (lower PPBC represent a better outcome)
Measured: Baseline, Week 4 and Week 12
Net changes of the GRA
Global response assessment (GRA) of satisfaction by the patient (categorized into -3, -2, -1, 0, 1, 2, 3, indicating markedly worse to markedly improved) at 1 and 3 months after the treatment day. An improvement of GRA by 2 scales is considered effective.
Measured: Baseline, Week 4 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start5 Jun 2020
- Primary completion31 May 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Urinary Bladder, OveractiveStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, multi-center, randomized, open label study in sexually active male OAB patients treated with behavior therapy alone or behavior therapy plus mirabegron 50mg OD in a 1:2 ratio.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tsang-Tang Hsieh, MD, Study chair, Institutional Review Board Chang Gung Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420533
- Sponsor's protocol ID
- 202000790A3
- Status last verified
- Oct 2022
- First submitted
- 2 Jun 2020
- Last updated
- 5 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abrams 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 11857671Chuang YC, Liu SP, Lee KS, Liao L, Wang J, Yoo TK, Chu R, Sumarsono B. Prevalence of overactive bladder in China, Taiwan and South Korea: Results from a cross-sectional, population-based study. Low Urin Tract Symptoms. 2019 Jan;11(1):48-55. doi: 10.1111/luts.12193. Epub 2017 Oct 2.
PubMed 28967230Irwin DE, Milsom I, Reilly K, Hunskaar S, Kopp Z, Herschorn S, Coyne KS, Kelleher CJ, Artibani W, Abrams P. Overactive bladder is associated with erectile dysfunction and reduced sexual quality of life in men. J Sex Med. 2008 Dec;5(12):2904-10. doi: 10.1111/j.1743-6109.2008.01000.x.
PubMed 19090944Coyne KS, Sexton CC, Thompson C, Kopp ZS, Milsom I, Kaplan SA. The impact of OAB on sexual health in men and women: results from EpiLUTS. J Sex Med. 2011 Jun;8(6):1603-15. doi: 10.1111/j.1743-6109.2011.02250.x. Epub 2011 Apr 14.
PubMed 21492396Yamaguchi O, Chapple CR. Beta3-adrenoceptors in urinary bladder. Neurourol Urodyn. 2007;26(6):752-6. doi: 10.1002/nau.20420.
PubMed 17600372Cirino G, Sorrentino R, di Villa Bianca Rd, Popolo A, Palmieri A, Imbimbo C, Fusco F, Longo N, Tajana G, Ignarro LJ, Mirone V. Involvement of beta 3-adrenergic receptor activation via cyclic GMP- but not NO-dependent mechanisms in human corpus cavernosum function. Proc Natl Acad Sci U S A. 2003 Apr 29;100(9):5531-6. doi: 10.1073/pnas.0931347100. Epub 2003 Apr 21.
PubMed 12707413Gur S, Peak T, Yafi FA, Kadowitz PJ, Sikka SC, Hellstrom WJ. Mirabegron causes relaxation of human and rat corpus cavernosum: could it be a potential therapy for erectile dysfunction? BJU Int. 2016 Sep;118(3):464-74. doi: 10.1111/bju.13515. Epub 2016 May 26.
PubMed 27124860Yilmaz-Oral D, Kaya-Sezginer E, Askin D, Hamurtekin Y, Gur S. Mirabegron, A Selective beta3-Adrenoceptor Agonist Causes an Improvement in Erectile Dysfunction in Diabetic Rats. Exp Clin Endocrinol Diabetes. 2021 Mar;129(4):296-302. doi: 10.1055/a-0869-7493. Epub 2019 Apr 12.
PubMed 30978726Wu TH, Shen YC, Lee WC, Wang HJ, Chuang YC. Effect of mirabegron on erectile function in sexually active men with bothersome overactive bladder symptoms. J Chin Med Assoc. 2020 Jan;83(1):55-59. doi: 10.1097/JCMA.0000000000000208.
PubMed 31567878
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Behavior Therapy and Behavior Therapy Plus Mirabegron 50mg in Sexually Active Men With Bothersome Overactive Bladder Symptoms - A Multicenter, Randomized Study
- ClinicalTrials.gov ID
- NCT04420533
- Acronym / sponsor ID
- 202000790A3
- Conditions
- Urinary Bladder, Overactive, Sexual Behavior, Sexual Activity, Behavior Therapy, Sexual Function Disturbances
- Keywords
- overactive bladder, mirabegron 50mg
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 9 Jun 2020 (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.
The objective of this study is to evaluate and compare the therapeutic effects on OAB symptoms, and sexual functions, in terms of erectile function and ejaculatory function, in sexually active OAB male treated with behavior therapy or behavior therapy plus Mirabegron (50 mg).
Detailed description
Overactive bladder (OAB) syndrome is a subset of storage-predominant lower urinary tract symptoms (LUTS) and has a significant impact on quality of life. Men with OAB generally experience a reduced quality of life, which may include a negative impact on sexual function. A previous study revealed that OAB is associated with erectile dysfunction (ED; prevalence odds ratio, 1.5; 95% confidence interval, 1.1-2.2) to a level comparable with that of hypertension or diabetes, both of which are known risk factors for ED. Furthermore, men with OAB were nine and seven times more likely to report diminished sexual enjoyment and decreased sexual activity, respectively, due to urinary symptoms than men without urinary symptoms.
Behavior therapies are designed as first- line treatment for the treatment of OAB with or without concomitant medication. Mirabegron, a selective β3 adrenoceptor agonist, is indicated for the treatment of OAB. Earlier research studying the role and distribution of β3-adrenoreceptors revealed that the receptors exert other physiological functions such as lipolysis and are present not only in adipose tissue but also in human gall bladder, colon, prostate, skeletal muscles and corpus cavernosum (CC) smooth muscles. It was found that activation by a selective experimental β3-receptor agonist, BRL 37344, elicited relaxation of human CC smooth muscle via a cGMP-dependent but NO-independent mechanism, leading to observable β3-receptor-mediated vasorelaxant tone of CC. The potential effect of β3-receptor agonism at human CC mediated by highly selective mirabegron in both human CC and rat CC that mirabegron markedly relaxed isolated CC strips by activating β3-adrenoceptors localized in cavernosal smooth muscle cells, independently of the NO-cGMP pathway. Recently, intra-cavernosal injection of mirabegron improved erectile function and neurogenic relaxation of corpus cavernosum in diabetic rats.
These early results have spurred research interest in mirabegron-induced CC relaxation and encouraged further clinical studies observing and evaluating the effect of mirabegron on male sexual function. Researchers at Johns Hopkins University has recently completed recruitment of a phase 1 interventional trial (NCT02916693) that aimed to address the hypothesis that activation of β3-adrenoceptors by mirabegron offers an alternative pharmacologic pathway for the treatment of erectile dysfunction. A preliminary small-scale prospective interventional study including 128 male LUTS patients treated with mirabegron 50 mg, 34 of whom had diagnosis of OAB and were sexually active, showed that mirabegron usage did not improve erectile function, as evaluated by International Index of Erectile Function (IIEF-5 4.9% decrease at 4-week; p = 0.106, and 9.1% decrease at 12-week follow-up; p = 0.077). However, the IIEF-5 was significantly decreased in the higher baseline IIEF-5 (≥17) group (11.7% decrease; p = 0.044), noncoronary artery disease (13.2%; p = 0.007) group and non-DM group (13.9% decrease; p = 0.021) at 12-week follow-up.
The accumulated research output warrants the initiation of a prospective study involving a larger patient cohort to evaluate the effect of mirabegron on male sexual function in addition to alleviate OAB symptoms. The objective of this study is to evaluate and compare the therapeutic effects on OAB symptoms, and sexual functions, in terms of erectile function and ejaculatory function, in sexually active OAB male treated with behavior therapy or behavior therapy plus Mirabegron (50 mg).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, multi-center, randomized, open label study in sexually active male OAB patients treated with behavior therapy alone or behavior therapy plus mirabegron 50mg OD in a 1:2 ratio.
| Arm | Type | Receives |
|---|---|---|
| Behavior therapy alone | Active comparator | Behavioral: Behavior therapy aloneBehavior therapy alone |
| Behavior therapy plus mirabegron 50mg | Experimental | Behavioral: Behavior therapy alone, Drug: Mirabegron 50 MG Extended Release Oral TabletBehavior therapy plus Betmiga prolonged-release tablets (mirabegron) 50mg QDAC PO |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sexually active men with OAB ≥ 20 years
- Diagnosed with OAB based on OABSS (OABSS urgency score of ≥2 and sum score of ≥3)
- Patients can sign informed consent and record voiding diary
Key exclusion criteria (11 listed)
- Concurrent use of PDE5 inhibitor or testosterone therapy during study period
- History of stress urinary incontinence
- Neurologic conditions associated with OAB symptoms
- Evidence of active urinary tract infection or urinary tract stone at screening
- Confirmed or suspected genitourinary tract or pelvic malignancy
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 |
|---|---|---|
| Behavior therapy alone1. reduction of fluid intake at specific times aimed at reducing urinary frequency when most inconvenient; 2. moderation of intake of caffeine or alcohol, which may have a diuretic and irritant effect, thereby increasing fluid output and enhancing frequency, urgency and nocturia; 3. use of relaxed and double-voiding techniques; 4. urethral milking to prevent post-micturition dribble; 5. distraction techniques such as penile squeeze, breathing exercises, perineal pressure, and mental tricks to take the mind off the bladder and toilet, to help control storage symptoms; 6. bladder retraining that encourages men to hold on when they have sensory urgency; 7. reviewing the medication and optimising the time of administration or substituting drugs for others that have fewer urinary effects (these recommendations apply especially to diuretics); 8. providing necessary assistance when there is impairment of dexterity, mobility or mental state; 9. treatment of constipation. | Behavioural | Behavior therapy alone, Behavior therapy plus mirabegron 50mg |
| Mirabegron 50 MG Extended Release Oral TabletAlso: Mirabegron 50 MGBetmiga prolonged-release tablets (mirabegron) 50mg QDAC PO | Drug | Behavior therapy plus mirabegron 50mg |
Primary outcome
Change from baseline in OABSS at Week 12
Time frame: Baseline and Week 12
Change from baseline in OABSS (Overactive Bladder Symptom Score) at Week 12 (lower OABSS score represent a better outcome)
Change from baseline in IIEF-5 at Week 12
Time frame: Baseline and Week 12
Change from baseline in IIEF-5 (International Index of Erectile Function) at Week 12 (higher IIEF-5 score represent a better outcome)
11 secondary outcomes
Change from baseline in OABSS at Week 4
Time frame: Baseline and Week 4
Change from baseline in IIEF-5 at Week 4
Time frame: Baseline and Week 4
Change from baseline in MSHQ-EjD Short Form score at Week 4
Time frame: Baseline and Week 4
Change from baseline in MSHQ-EjD Short Form score at Week 12
Time frame: Baseline and Week 12
Net change of Frequency episode, nocturia episode, urgency episode, UUI episodes in 3-day voiding diary from baseline to 1 and 3 months after the treatment day
Time frame: Baseline, Week 4 and Week 12
Net change of Qmax from baseline to 1 and 3 months after the treatment day
Time frame: Baseline, Week 4 and Week 12
Net change of voided volume from baseline to 1 and 3 months after the treatment day
Time frame: Baseline, Week 4 and Week 12
Net change of PVR volume from baseline to 1 and 3 months after the treatment day
Time frame: Baseline, Week 4 and Week 12
Net change of IPSS from baseline to 1 and 3 months after the treatment day
Time frame: Baseline, Week 4 and Week 12
Net change of PPBC score from baseline to 1 and 3 months after the treatment day
Time frame: Baseline, Week 4 and Week 12
Net changes of the GRA
Time frame: Baseline, Week 4 and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Background: 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.
- Background: PubMed 28967230Chuang YC, Liu SP, Lee KS, Liao L, Wang J, Yoo TK, Chu R, Sumarsono B. Prevalence of overactive bladder in China, Taiwan and South Korea: Results from a cross-sectional, population-based study. Low Urin Tract Symptoms. 2019 Jan;11(1):48-55. doi: 10.1111/luts.12193. Epub 2017 Oct 2.
- Background: PubMed 19090944Irwin DE, Milsom I, Reilly K, Hunskaar S, Kopp Z, Herschorn S, Coyne KS, Kelleher CJ, Artibani W, Abrams P. Overactive bladder is associated with erectile dysfunction and reduced sexual quality of life in men. J Sex Med. 2008 Dec;5(12):2904-10. doi: 10.1111/j.1743-6109.2008.01000.x.
- Background: PubMed 21492396Coyne KS, Sexton CC, Thompson C, Kopp ZS, Milsom I, Kaplan SA. The impact of OAB on sexual health in men and women: results from EpiLUTS. J Sex Med. 2011 Jun;8(6):1603-15. doi: 10.1111/j.1743-6109.2011.02250.x. Epub 2011 Apr 14.
- Background: PubMed 17600372Yamaguchi O, Chapple CR. Beta3-adrenoceptors in urinary bladder. Neurourol Urodyn. 2007;26(6):752-6. doi: 10.1002/nau.20420.
- Background: PubMed 12707413Cirino G, Sorrentino R, di Villa Bianca Rd, Popolo A, Palmieri A, Imbimbo C, Fusco F, Longo N, Tajana G, Ignarro LJ, Mirone V. Involvement of beta 3-adrenergic receptor activation via cyclic GMP- but not NO-dependent mechanisms in human corpus cavernosum function. Proc Natl Acad Sci U S A. 2003 Apr 29;100(9):5531-6. doi: 10.1073/pnas.0931347100. Epub 2003 Apr 21.
- Background: PubMed 27124860Gur S, Peak T, Yafi FA, Kadowitz PJ, Sikka SC, Hellstrom WJ. Mirabegron causes relaxation of human and rat corpus cavernosum: could it be a potential therapy for erectile dysfunction? BJU Int. 2016 Sep;118(3):464-74. doi: 10.1111/bju.13515. Epub 2016 May 26.
- Background: PubMed 30978726Yilmaz-Oral D, Kaya-Sezginer E, Askin D, Hamurtekin Y, Gur S. Mirabegron, A Selective beta3-Adrenoceptor Agonist Causes an Improvement in Erectile Dysfunction in Diabetic Rats. Exp Clin Endocrinol Diabetes. 2021 Mar;129(4):296-302. doi: 10.1055/a-0869-7493. Epub 2019 Apr 12.
- Background: PubMed 31567878Wu TH, Shen YC, Lee WC, Wang HJ, Chuang YC. Effect of mirabegron on erectile function in sexually active men with bothersome overactive bladder symptoms. J Chin Med Assoc. 2020 Jan;83(1):55-59. doi: 10.1097/JCMA.0000000000000208.
- Management of Non-neurogenic Male LUTS. European Association of Urology, 2019 GuidelinesLink provided by the sponsor.
- ClinicalTrials.gov Identifier NCT02916693, Mirabegron For Erectile DysfunctionLink provided by the sponsor.
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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.
Tsang-Tang Hsieh, MD study chair
Institutional Review Board Chang Gung Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavior therapy alone and Mirabegron 50 MG Extended Release Oral Tablet in people with Urinary Bladder, Overactive and Sexual Behavior, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 11 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: finished, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in OABSS at Week 12 (time frame: Baseline and Week 12). The study lists 2 primary outcomes in all. 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 NCT04420533, which also lists 9 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 5 Oct 2022; AzTrials last refreshed its copy on 27 Oct 2026.