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NCT Number: NCT02320773

A Prospective Non-interventional Study in Overactive Bladder (OAB) Patients Prescribed Betmiga® as Part of Routine Clinical Practice

A study to understand the impact of Betmiga® on patients quality of life, satisfaction with treatment, how long patients remain on treatment, patterns of healthcare resource utilisation, and safety as prescribed by the physicians in routine clinical practice.

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Key information

Conditions

Urgency Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Overactive Bladder Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder Overactive Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site CZ42003 Fakultni nemocnice Brno-Bohunice, Brno, Czechia

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About this study

Single arm, hybrid model study, observing patients on Betmiga under conditions of routine clinical practice, with some element of retrospective data collection 2 years prior to enrolment of the study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who have been diagnosed with OAB symptoms at Visit 1 of this study. OAB is defined by the International Urogynecological Association (IUGA)/International Continence Society (ICS) 2010 joint report as urinary urgency, with or without urinary incontinence, usually with frequency and nocturia, with no proven infection or other obvious pathology.
  • Patients whose physician has made the decision to prescribe Betmiga® as part of routine clinical practice and who are about to start treatment.

Exclusion criteria

  • Patients who are currently taking Betmiga®.
  • Contraindication(s) as per the Betmiga® Summary of Product Characteristics (SPC).

Treatment and study plan

Betmiga®

Drug

Oral

Other names: YM178, Mirabegron, Myrbetriq®, Betanis®

Primary outcomes

  1. Change from baseline in QoL based on the OAB-q subscales

    Time frame: Baseline up to 12 months post-baseline

    Quality of life (QoL) based on the Overactive bladder questionnaire (OAB-q) subscales

Secondary outcomes

  1. Change from baseline in patient treatment satisfaction based on TS-VAS

    Time frame: Baseline up to 12 months post-baseline

    Based on Treatment Satisfaction Visual Analogue Scale (TS-VAS)

  2. Change from baseline in QoL based on the EQ-5D-5L subscales and WPAI:SHP

    Time frame: Baseline up to 12 months post-baseline

    QoL based on Work Productivity Activity Index:Specific Health Problem (WPAI:SHP) and EUROQOL 5-DIMENSIONS (EQ5D)

  3. Summary of utilisation of healthcare resources related to the management of OAB

    Time frame: From enrollment to end of study (up to 12 months)

    Overactive bladder (OAB) healthcare resources are captured by the investigator and include: healthcare visits, medical interventions, number of incontinence pads used in last 7 days, invasive/surgical treatments of OAB symptoms and any other investigations of OAB (including clinical interpretation if available)

  4. Frequency summary of disease progression

    Time frame: From enrollment to end of study (up to 12 months

    Disease progression is defined by occurrence of invasive/surgical treatment of OAB symptoms during the study. Overactive Bladder (OAB) treatments include e.g. Botulinum toxin type A, Sacral Neural Stimulation (SNS), Percutaneous tibial nerve stimulation (PTNS)

  5. Change from baseline in incontinence status during the study

    Time frame: Baseline up to 12 months post-baseline

  6. Safety assessed by recording of AEs and ADRs during the study

    Time frame: From enrollment to end of study (up to 12 months)

    Adverse Events (AEs), Adverse Drug Reaction (ADR)

  7. Summary of prescription status to assess treatment patterns and persistence with treatment

    Time frame: Baseline up to 12 months post-baseline

    This composite summary includes the following items:

    • Number and percentage of patients who switched treatment, and to what treatment they were switched.
    • Number and percentage of patients who stopped treatment and reasons associated with discontinuation.
    • Number of treatment days on current treatment.
    • Time from treatment initiation to discontinuation or switching to another treatment.
    • Time from treatment initiation to prescription of additional oral OAB treatment and reasons for combination treatment.

Sponsors and collaborators

Lead sponsor

Astellas Pharma Europe Ltd.

Industry

Registry information

Official study title

Non-Interventional Study Assessing Quality of Life, Treatment Satisfaction, Resource Utilisation, and Persistence With Treatment in Overactive Bladder (OAB) Patients Prescribed Betmiga® - A Multicenter Non-interventional Post Authorisation Study (PAS)

Acronym: BELIEVE

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 19, 2014
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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