Status:
COMPLETED
Comparative Study Between Behavior Therapy and Behavior Therapy Plus Mirabegron in Sexually Active Men With OAB Symptoms
Lead Sponsor:
Chang Gung Memorial Hospital
Conditions:
Urinary Bladder, Overactive
Sexual Behavior
Eligibility:
MALE
20+ years
Phase:
NA
Brief 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 mal...
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 qu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04420533
Start Date
June 5 2020
End Date
August 31 2022
Last Update
October 5 2022
Active Locations (1)
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1
Chang Gung Memorial Hospital, Chang Gung University College of Medicine
Kaohsiung City, Taiwan, 833