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Completed

NCT Number: NCT05067478

Composur: Study to Understand the Performance of Vibegron in Participants with Overactive Bladder (OAB)

This study will evaluate the treatment satisfaction, discontinuation, reasons for discontinuation, quality of life, healthcare resource utilization, and safety with Vibegron for the treatment of OAB in the context of real-world clinical practice.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Urology Centers of Alabama, Homewood, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of overactive bladder (OAB) with or without urgency urinary incontinence
  • Symptoms of OAB for at least 3 months prior to the Baseline Visit
  • Willing and able to complete electronic patient-reported outcomes questionnaires monthly for a minimum of 1 year
  • Previous exposure to anticholinergics or mirabegron monotherapy and/or mirabegron plus solifenacin combination therapy prior to initiation of vibegron

Exclusion criteria

  • Any contraindication to the use of vibegron per the United States label
  • History of OAB treatment with botulinum toxin A; sacral neuromodulation; percutaneous tibial nerve stimulation; external beam radiation therapy; urinary stents within the last 6 months; pelvic or lower urinary tract surgery within the last 6 months; and urethral catheterizations within the last 3 months prior to the Baseline Visit
  • History of mixed incontinence where stress incontinence is the predominant form (as determined by the investigator)
  • Participants at risk of urinary retention (as determined by the investigator)
  • Neurologic conditions associated with OAB symptoms, e.g., multiple sclerosis
  • Pregnant or breastfeeding or plans to do so during the study
  • Use of vibegron prior to the Baseline Visit either prescribed or in a previous vibegron clinical trial where the participant was on vibegron
  • Anyone who, at the discretion of the investigator, is not suitable for treatment with a beta 3 agonist for OAB for any reason

Treatment and study plan

Vibegron

Drug

Vibegron to be administered.

Other names: GEMTESA

Primary outcomes

  1. Mean Satisfaction Domain Score as Assessed by the Overactive Bladder Satisfaction with Treatment Questionnaire (OAB-SAT-q)

    Time frame: Month 3

    The OAB-SAT-q is an 11-item questionnaire designed to assess participant's satisfaction with overactive bladder treatment in the clinical setting. It includes 3 subscales (satisfaction, side effects, endorsement) and 2 single-item assessments (convenience, preference), with a 4-week recall period. The OAB-SAT-q is scored by domains ranging from 0-100. Scores for the Convenience item range from 0-100. The Preference item is calculated as a percentage. Higher scores indicate higher levels of treatment satisfaction, endorsement, and convenience.

  2. Mean Satisfaction Domain Score as Assessed by the OAB-SAT-q

    Time frame: Month 6

    The OAB-SAT-q is an 11-item questionnaire designed to assess participant's satisfaction with overactive bladder treatment in the clinical setting. It includes 3 subscales (satisfaction, side effects, endorsement) and 2 single-item assessments (convenience, preference), with a 4-week recall period. The OAB-SAT-q is scored by domains ranging from 0-100. Scores for the Convenience item range from 0-100. The Preference item is calculated as a percentage. Higher scores indicate higher levels of treatment satisfaction, endorsement, and convenience.

  3. Mean Satisfaction Domain Score as Assessed by the OAB-SAT-q

    Time frame: Month 12

    The OAB-SAT-q is an 11-item questionnaire designed to assess participant's satisfaction with overactive bladder treatment in the clinical setting. It includes 3 subscales (satisfaction, side effects, endorsement) and 2 single-item assessments (convenience, preference), with a 4-week recall period. The OAB-SAT-q is scored by domains ranging from 0-100. Scores for the Convenience item range from 0-100. The Preference item is calculated as a percentage. Higher scores indicate higher levels of treatment satisfaction, endorsement, and convenience.

Secondary outcomes

  1. Percentage of Positive Responders to Individual Treatment Satisfaction Questions 1-3 and 11 as Assessed by the OAB-SAT-q

    Time frame: Month 3, Month 6 and Month 12

  2. Mean Scores on the Side Effects, Endorsement, Convenience, and Preference Domains as Assessed by the OAB-SAT-q

    Time frame: Month 3, Month 6 and Month 12

  3. Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

    Time frame: Up to Month 12

  4. Mean Duration of Vibegron Treatment

    Time frame: Month 3, Month 6 and Month 12

  5. Number of Participants Discontinuing Vibegron Treatment for the Indicated Reasons

    Time frame: Month 3, Month 6 and Month 12

  6. Percentage of Participants Discontinuing Vibegron Treatment for the Indicated Reasons

    Time frame: Month 3, Month 6 and Month 12

Sponsors and collaborators

Lead sponsor

Urovant Sciences GmbH

Industry

Registry information

Official study title

Composur, a Patient-centric, Phase IV, Open-label, Prospective, Real World US Study to Evaluate Vibegron on Patient Treatment Satisfaction, Quality of Life, and Healthcare Resource Utilization in Overactive Bladder

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 5, 2021
Registry last updated
Dec 27, 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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