Efficacy And Safety Of Combination Therapy For Treatment Of Overactive Bladder In Male Patients With Benign Prostatic Hyperplasia.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-31

Study Completion Date

2022-12-31

Brief Summary

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The purpose of this study is to investigate the safety and efficacy of combination therapy involving β3-adrenoceptor agonist, mirabegron, and α-blockers for the treatment of OAB symptoms in male patients with BPH.

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Detailed Description

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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.

Conditions

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Overactive Bladder Benign Prostatic Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment Group

(Mirabegron + Tamsulosin)

Group Type ACTIVE_COMPARATOR

Mirabegron

Intervention Type DRUG

50mg of mirabegron per day will be given.

Tamsulosin

Intervention Type DRUG

0.4mg of flomax per day.

Control Group

(Placebo + Tamsulosin)

Group Type PLACEBO_COMPARATOR

Tamsulosin

Intervention Type DRUG

0.4mg of flomax per day.

Interventions

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Mirabegron

50mg of mirabegron per day will be given.

Intervention Type DRUG

Tamsulosin

0.4mg of flomax per day.

Intervention Type DRUG

Other Intervention Names

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Myrbetriq Flomax

Eligibility Criteria

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Inclusion Criteria

* Male patients over the age of 50
* Clinical BPH on stable dose of alpha-blocker therapy for more than 1 month
* OAB symptoms (frequency, urgency, nocturia, urgency incontinence)

Exclusion Criteria

* Post-void residual (PVR) \> 200mL
* Active, culture-proven urinary tract infection
* Acute/chronic prostatitis
* Previous lower urinary tract malignancy (i.e. bladder, prostate malignancy)
* History of cystolithiasis
* Previous pelvic surgery (i.e. prostatectomy, cystectomy, recent pelvic/endourologic instrumentation including cystoscopy, nephroscopy, ureteral stent insertion, Transrectal Ultrasound (TRUS) biopsy)
* Previous pelvic radiation

Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No