Comparative Study Between Behavior Therapy and Behavior Therapy Plus Mirabegron in Sexually Active Men With OAB Symptoms

• Status: Recruiting
• Trial end date: 2022-05-31
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chang Gung Memorial Hospital
• Treatments: Mirabegron

Criteria

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