Sexual Behavior Clinical Trial
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
Verified date | October 2022 |
Source | Chang Gung Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 150 |
Est. completion date | August 31, 2022 |
Est. primary completion date | May 31, 2022 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Chang Gung Memorial Hospital, Chang Gung University College of Medicine | Kaohsiung |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital |
Taiwan,
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. — View Citation
Chuang 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. — View Citation
Cirino 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. Epub 2003 Apr 21. — View Citation
Coyne 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. — View Citation
Gur 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. — View Citation
Irwin 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. — View Citation
Wu 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. — View Citation
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Yilmaz-Oral D, Kaya-Sezginer E, Askin D, Hamurtekin Y, Gur S. Mirabegron, A Selective ß3-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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | Baseline and Week 12 | |
Primary | 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) | Baseline and Week 12 | |
Secondary | 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) | Baseline and Week 4 | |
Secondary | 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) | Baseline and Week 4 | |
Secondary | 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) | Baseline and Week 4 | |
Secondary | 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) | Baseline and Week 12 | |
Secondary | 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) | Baseline, Week 4 and Week 12 | |
Secondary | 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) | Baseline, Week 4 and Week 12 | |
Secondary | 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) | Baseline, Week 4 and Week 12 | |
Secondary | 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) | Baseline, Week 4 and Week 12 | |
Secondary | 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) | Baseline, Week 4 and Week 12 | |
Secondary | 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) | Baseline, Week 4 and Week 12 | |
Secondary | 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. | Baseline, Week 4 and Week 12 |
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