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Completed

NCT Number: NCT02386072

A Prospective, Observational, Multicenter Study of Patients Following Initiation of a New Course of Treatment for Overactive Bladder (OAB)

A study to identify factors that are associated with improved effectiveness in pharmacologic therapy of Overactive Bladder, from the patient perspective primarily measured by OAB-Q-SF (Overactive Bladder Questionnaire Short Form)

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Key information

Conditions

Urinary Bladder Overactive 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 Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site CA1026, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with OAB (with or without urgency incontinence) by the treating HCP, with symptoms for at least three months prior to study enrollment
  • Initiating a new course of treatment with mirabegron or antimuscarinic medication (including patch formulation) for OAB, which may be first course of any treatment for OAB, restart or switch from one drug to another
  • Willing and able to complete PRO questionnaires with minimal assistance

Exclusion criteria

  • Current participation in clinical trials of OAB
  • Use of more than one OAB medication at time of enrollment
  • Patients whose OAB has been treated with onabotulinumtoxinA, sacral neuromodulation, percutaneous tibial nerve stimulation, external beam radiation (XRT), stents, surgery, or intermittent catheterization prior to or at time of enrollment
  • Neurologic conditions associated with OAB symptoms
  • Patients residing in a nursing home

Treatment and study plan

Mirabegron

Drug

oral

Other names: YM178, Betanis, Myrbetriq, Betmiga

antimuscarinic medication

Drug

oral

Other names: Ditropan XL, Gelnique, Enablex, Trosec, Sanctura, Oxybutynin IR, Vesicare, Oxytrol, Toviaz, Detrol

Primary outcomes

  1. Change from baseline in OAB-related QoL and symptom bother

    Time frame: Baseline, Month 1, 3, 6 and 12

    Overactive Bladder (OAB), Quality of Life (QoL). As measured by the Overactive Bladder Questionnaire Short Form (OAB-Q-SF) questionnaire scores

Secondary outcomes

  1. Effectiveness as measured by impression of severity of OAB

    Time frame: Baseline, Month 1, 3, 6 and 12

    Via the Patient Perception of Bladder Condition [PPBC]

  2. Effectiveness as measured by general health related QoL

    Time frame: Baseline, Month 1, 3, 6 and 12

    via the EuroQol 5D [EQ-5D]

  3. Persistence with OAB drug treatment

    Time frame: Baseline till End of Study (ESV) (up to month 12)

    The duration of time a patient continues to take the prescribed medication

  4. Use of additional (add-on) medications

    Time frame: Baseline till ESV (up to month 12)

    As reported by patients and HCP

  5. Switching of medication

    Time frame: Baseline till ESV (up to month 12)

    As reported by patients and HCP

  6. OAB drug treatment satisfaction

    Time frame: Baseline, month 1, 3, 6 and 12

    Via the Overactive Bladder Treatment Satisfaction Questionnaire (OAB-S)

  7. Reasons for switching of medication

    Time frame: Baseline till ESV (up to month 12)

    As reported by patients and HCP for each specific medication, number and percent

  8. Reasons for discontinuation of medication

    Time frame: Baseline till ESV (up to month 12)

    As reported by patients and HCP for each specific medication, number and percent

  9. Reasons for add-on medication

    Time frame: Baseline till ESV (up to month 12)

    As reported by patients and HCP for each specific medication, number and percent

  10. Reasons for dose titration

    Time frame: Baseline till ESV (up to month 12)

    As reported by patients and HCP for each specific medication

  11. Frequency of dose titration

    Time frame: Baseline till ESV (up to month 12)

    As reported by patients and HCP for each specific medication

  12. Safety profile as assessed by recording AEs and SAEs

    Time frame: Baseline till ESV (up to month 12)

    Adverse Events (AEs), Serious Adverse Events (SAEs)

Sponsors and collaborators

Lead sponsor

Astellas Scientific & Medical Affairs, Inc.

Industry

Registry information

Official study title

A Prospective, Non-interventional, Registry Study of Patients Initiating a Course of DrugTherapy for Overactive Bladder (OAB)

Acronym: PERSPECTIVE

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 11, 2015
Registry last updated
Oct 16, 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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