Efficacy And Safety Of Combination Therapy For Treatment Of Overactive Bladder In Male Patients With Benign Prostatic Hyperplasia.
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Benign Prostatic Hyperplasia
- Overactive Bladder
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Single Group AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 50 years and 90 years
- Gender
- Only males
Description
Mirabegron (MyrbetriqTM, Astellas Pharma Inc.) is a drug that is approved by the FDA for the treatment of overactive bladder (OAB) with symptoms of urinary frequency, urgency and urgency incontinence. Multiple studies have shown that this drug also has the potential to improve patient tolerability, ...
Mirabegron (MyrbetriqTM, Astellas Pharma Inc.) is a drug that is approved by the FDA for the treatment of overactive bladder (OAB) with symptoms of urinary frequency, urgency and urgency incontinence. Multiple studies have shown that this drug also has the potential to improve patient tolerability, compliance and subsequent patient quality of life without inducing unfavourable adverse events commonly associated with antimuscarinic medications. These adverse events include, but are not limited to, dry mouth, constipation, confusion, and acute urinary retention (AUR). Studies now have shown that mirabegron may also provide an effective treatment option for OAB in men with benign prostatic hyperplasia (BPH) without inducing the above mentioned adverse events. This study will look at the combination therapy of Mirabegron and Tamsulosin, versus Tamsulosin and placebo alone to prove that this treatment (Mirabegron and Tamsulosin) is effective for those men who suffer from both overactive bladder along with benign prostatic hyperplasia.
Tracking Information
- NCT #
- NCT02279615
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Anil Kapoor, MD, FRCSC McMaster University