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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

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
        • Universitatsklinikum 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
        • Universitatsklinikum Munster
      • 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 Marques de Valdecilla
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen Del Rocio
      • 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

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
Intervention / Treatment
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

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

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

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

June 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

June 9, 2014

First Submitted That Met QC Criteria

June 9, 2014

First Posted (Estimate)

June 11, 2014

Study Record Updates

Last Update Posted (Estimate)

April 18, 2016

Last Update Submitted That Met QC Criteria

April 14, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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