NCT02279615

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 31, 2014

Completed
7.1 years until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 19, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

October 10, 2014

Last Update Submit

March 17, 2021

Conditions

Overactive BladderBenign Prostatic Hyperplasia

Keywords

Overactive BladderBenign Prostatic HyperplasiaCombination Therapyβ3-Adrenoceptor AgonistMirabegronMyrbetriqα-Adrenoceptor AntagonistTamsulosinFlomax

Outcome Measures

Primary Outcomes (3)

  • International Prostate Symptom Score (IPSS)

    Measured before and after combination therapy.

    Treatment period: 4 weeks

  • Quality of Life Score (QoLS)

    Measured before and after combination therapy

    Treatment period: 4 weeks

  • Overactive Bladder Symptom Score (OABSS)

    Measured before and after combination therapy

    Treatment period: 4 weeks

Secondary Outcomes (1)

  • Adverse Events

    Timeline: 4 weeks

Study Arms (2)

Treatment Group

ACTIVE COMPARATOR

(Mirabegron + Tamsulosin)

Drug: MirabegronDrug: Tamsulosin

Control Group

PLACEBO COMPARATOR

(Placebo + Tamsulosin)

Drug: Tamsulosin

Interventions

MirabegronDRUG

50mg of mirabegron per day will be given.

Also known as: Myrbetriq
Treatment Group
TamsulosinDRUG

0.4mg of flomax per day.

Also known as: Flomax
Control GroupTreatment Group

Eligibility Criteria

Age50 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Healthcare Hamilton - McMaster Institute of Urology

Hamilton, Ontario, L8N4A6, Canada

Location

MeSH Terms

Conditions

Urinary Bladder, OveractiveProstatic Hyperplasia

Interventions

mirabegronTamsulosin

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsProstatic DiseasesGenital Diseases, MaleGenital Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Study Officials

  • Anil Kapoor, MD, FRCSC

    McMaster University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Taehyoung Lee, MD, PGY4

CONTACT

905-522-1155taehyoung.lee@medportal.ca

Camilla Tajzler, BA, CCRA

CONTACT

905-522-1155tajzlec@mcmaster.ca

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, FRCSC

Study Record Dates

First Submitted

October 10, 2014

First Posted

October 31, 2014

Study Start

December 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

March 19, 2021

Record last verified: 2021-03

Locations

CA(1)