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

Sponsor

St. Joseph's Healthcare Hamilton (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT02279615

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

16.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder Benign Prostatic Hyperplasia	Drug: Mirabegron Drug: Tamsulosin	Phase 4

Detailed 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, 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

EFFICACY AND SAFETY OF COMBINATION THERAPY WITH β3-ADRENOCEPTOR AGONIST (MIRABEGRON) AND α-ADRENOCEPTOR ANTAGONIST (TAMSULOSIN) FOR TREATMENT OF OVERACTIVE BLADDER IN MALE PATIENTS WITH BENIGN PROSTATIC HYPERPLASIA.

Anticipated Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Treatment Group (Mirabegron + Tamsulosin)	Drug: Mirabegron 50mg of mirabegron per day will be given. Other Names: Myrbetriq Drug: Tamsulosin 0.4mg of flomax per day. Other Names: Flomax
Placebo Comparator: Control Group (Placebo + Tamsulosin)	Drug: Tamsulosin 0.4mg of flomax per day. Other Names: Flomax

Arm

Intervention/Treatment

Active Comparator: Treatment Group

(Mirabegron + Tamsulosin)

Drug: Mirabegron

50mg of mirabegron per day will be given.

Other Names:

Myrbetriq

Drug: Tamsulosin

0.4mg of flomax per day.

Other Names:

Flomax

Placebo Comparator: Control Group

(Placebo + Tamsulosin)

Drug: Tamsulosin

0.4mg of flomax per day.

Other Names:

Flomax

Outcome Measures

Primary Outcome Measures

International Prostate Symptom Score (IPSS) [Treatment period: 4 weeks]
Measured before and after combination therapy.
Quality of Life Score (QoLS) [Treatment period: 4 weeks]
Measured before and after combination therapy
Overactive Bladder Symptom Score (OABSS) [Treatment period: 4 weeks]
Measured before and after combination therapy

Secondary Outcome Measures

Adverse Events [Timeline: 4 weeks]
Measured during treatment of combination therapy.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 90 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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