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

Overactive Bladder Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02279615
• Other study ID #: MIRTAM-2014OB
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 2021
• Est. completion date: December 2022

Study information

• Verified date: March 2021
• Source: St. Joseph's Healthcare Hamilton
• Contact: Taehyoung Lee, MD, PGY4
• Phone: 905-522-1155
• Email: taehyoung.lee[@]medportal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Overactive Bladder
• Prostatic Hyperplasia
• Urinary Bladder, Overactive

Intervention

Drug:
• Mirabegron
50mg of mirabegron per day will be given.
• Tamsulosin
0.4mg of flomax per day.

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton - McMaster Institute of Urology	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Prostate Symptom Score (IPSS)	Measured before and after combination therapy.	Treatment period: 4 weeks
Primary	Quality of Life Score (QoLS)	Measured before and after combination therapy	Treatment period: 4 weeks
Primary	Overactive Bladder Symptom Score (OABSS)	Measured before and after combination therapy	Treatment period: 4 weeks
Secondary	Adverse Events	Measured during treatment of combination therapy.	Timeline: 4 weeks