An Observational Study of BOTOX® for the Management of Urinary Incontinence in Patients With Idiopathic Overactive Bladder (GRACE)

April 14, 2016 updated by: Allergan
This study will evaluate real world pattern of use of BOTOX® in actual clinical practice in patients with idiopathic overactive bladder (iOAB) with urinary incontinence whose symptoms have not been adequately managed by oral anticholinergic therapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
515

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Mergentheim, Germany, 97980
        • David Brix
      • Berlin, Germany, 10551
        • Urologie Turmschtraße
      • Berlin, Germany, 12099
        • Uwe-Carsten
      • Berlin, Germany, 12247
        • Albrecht Kastein
      • Berlin, Germany, 14197
        • ATURO
      • Burgdorf, Germany, 31303
        • MVZ Burgdorf
      • Dresden, Germany, 01099
        • Ev.-Luth. Diakonissenanstalt Dresden
      • Emmendingen, Germany, 79312
        • Stefan Carl
      • Frankfurt, Germany, 60439
        • Zentrum für Urologie FFM
      • Göttingen, Germany, 37075
        • Georg-August-Universität Göttingen
      • Halle (Saale), Germany, 06120
        • Universitätsklinikum Halle (Saale)
      • Hamburg, Germany, 22081
        • Urologikum Hamburg
      • Hamburg, Germany, 22359
        • Urologische Praxis Volksdorf
      • Herne, Germany, 44649
        • Claudia Olszak-Warnat
      • Kaiserslautern, Germany, 67655
        • Westpfalz-Klinikum Kaiserslautern
      • Kiel, Germany, 24103
        • Urologie Zentrum Kiel
      • Lampertheim, Germany, 68623
        • Joachim Weiß
      • Landshut, Germany, 84028
        • Uro- Vital-Zentrum, GP Hellmeier, Krause et al
      • Leipzig, Germany, 04109
        • Tom Kempe
      • Markkleeberg, Germany, 04416
        • Institut Dr. Schulze
      • Mülheim, Germany, 45468
        • Elke Stagge
      • Münster, Germany, 48149
        • Universitätsklinikum Münster
      • Nürnberg, Germany, 90409
        • Urologen am Stadtpark
      • Osnabrück, Germany, 49076
        • Urologicum Osnabrück
      • Reutlingen, Germany, 72764
        • Simone Maier
      • Salzatal OT Schiepzig, Germany, 06198
        • Andres Melchior
      • Sangerhausen, Germany, 06526
        • Andreas Reinhard Wicht
      • Singen, Germany, 78224
        • Franz Hirschle
      • Stuttgart, Germany, 70174
        • Wolfgang Theurer
      • Tuttlingen, Germany, 78532
        • Benjamin Fischer
      • Tuttlingen, Germany, 78532
        • Dietmar Jung
      • Villingen-Schwenningen, Germany, 78052
        • Kontinenzzentrum Südwest
  • Spain
      • Burgos, Spain, 09006
        • Hospital Universitario Burgos
      • Gijón, Spain, 33394
        • Hospital de Cabueñes
      • Málaga, Spain, 29010
        • Hospital Virgen de la Victoria
      • Ourense, Spain, 32005
        • Complejo Hospitalario Universitario Ourense
      • Oviedo, Spain, 33011
        • Hospital Universitario Central de Asturias
      • Salamanca, Spain, 37007
        • Hospital Universitario Salamanca
      • Santander, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocío
      • Sevilla, Spain, 41014
        • Hospital De Valme
  • Sweden
      • Halmstad, Sweden, 30185
        • Urologimottagningen, Hallands Sjukhus Halmstad
      • Stockholm, Sweden, 11883
        • Urologiska kliniken, Södersjukhuset AB
      • Stockholm, Sweden, 17177
        • Karolinska Hospital
      • Stockholm, Sweden, 18288
        • Karolinska Hospital
      • Stockholm, Sweden, 18288
        • Kvinnokliniken, Danderyds Sjukhus AB
      • Västervik/Kalmar, Sweden, 59381
        • Kirurgkliniken, Västervik Sjukhus
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Queen Elizabeth Hospital, Queen Elizabeth Medical Centre, Edgbaston
      • Glasgow, Lanarkshire, United Kingdom, G51 4TF
        • Southern General Hospital
      • Leeds, West Yorkshire, United Kingdom, LS9 7TF
        • Leeds Teaching Hospitals NHS Trust, St. James's University Hospital
      • London, United Kingdom, NW1 2BU
        • University College London Hospitals NHS Foundation Trust
      • London, United Kingdom, W2 1NY
        • Imperial College Healthcare NHS Trust, The Bays, St Mary's Hospital
      • Prescot, Merseyside, United Kingdom, L35 5DR
        • St Helens & Knowsley Teaching Hospitals NHS Trust, Whiston Hospital
      • Salisbury, Wiltshire, United Kingdom, SP2 8BJ
        • Salisbury NHS Foundation Trust, Salisbury District Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients With Urinary Incontinence Due to iOAB

Description

Inclusion Criteria:

  • No prior treatment with botulinum toxin Type A for treatment of iOAB

Exclusion Criteria:

  • Treatment with any botulinum toxin Type A within 18 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients With Urinary Incontinence Due to iOAB
Patients with urinary incontinence due to iOAB treated with BOTOX® in accordance with physician standard practice.
Biological: botulinum toxin Type A
botulinum toxin Type A administered in accordance with physician standard practice.
Other Names:
  • BOTOX®
  • onabotulinumtoxinA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of Patients Who have Greatly Improved or Improved on the 4-Point Treatment Benefit Scale (TBS)
Time Frame: Baseline, Week 12
Baseline, Week 12
Change From Baseline in Number of Urinary Incontinence Episodes
Time Frame: Baseline, Week 12
Baseline, Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Time to Re-Injection of BOTOX®
Time Frame: 12 Months
12 Months
Number of Nocturia Episodes
Time Frame: 12 Months
12 Months
Usage of Incontinence Support Products
Time Frame: 12 Months
12 Months
Percentage of Patients Who Have at Least a 50% Reduction in Urinary Incontinence and Urinary Urgency Incontinence
Time Frame: Baseline, 12 Months
Baseline, 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 9, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MAF/AGN/NS/OAB/002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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