Comparative Study Between Behavior Therapy and Behavior Therapy Plus Mirabegron in Sexually Activ… (NCT04420533) | Clinical Trial Compass
CompletedNot Applicable
Comparative Study Between Behavior Therapy and Behavior Therapy Plus Mirabegron in Sexually Active Men With OAB Symptoms
Taiwan150 participantsStarted 2020-06-05
Plain-language 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).
Who can participate
Age range
20 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.