An Observational Study of BOTOX® for the Management of Urinary Incontinence in Patients With Idiopathic Overactive Bladder
GRACE
1 other identifier
observational
515
4 countries
54
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2014
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 9, 2014
CompletedFirst Posted
Study publicly available on registry
June 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedApril 18, 2016
April 1, 2016
1.6 years
June 9, 2014
April 14, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Patients Who have Greatly Improved or Improved on the 4-Point Treatment Benefit Scale (TBS)
Baseline, Week 12
Change From Baseline in Number of Urinary Incontinence Episodes
Baseline, Week 12
Secondary Outcomes (4)
Time to Re-Injection of BOTOX®
12 Months
Number of Nocturia Episodes
12 Months
Usage of Incontinence Support Products
12 Months
Percentage of Patients Who Have at Least a 50% Reduction in Urinary Incontinence and Urinary Urgency Incontinence
Baseline, 12 Months
Study Arms (1)
Patients With Urinary Incontinence Due to iOAB
Patients with urinary incontinence due to iOAB treated with BOTOX® in accordance with physician standard practice.
Interventions
botulinum toxin Type A administered in accordance with physician standard practice.
Eligibility Criteria
Patients With Urinary Incontinence Due to iOAB
You may qualify if:
- No prior treatment with botulinum toxin Type A for treatment of iOAB
You may not qualify if:
- Treatment with any botulinum toxin Type A within 18 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (54)
David Brix
Bad Mergentheim, 97980, Germany
Urologie Turmschtraße
Berlin, 10551, Germany
Uwe-Carsten
Berlin, 12099, Germany
Albrecht Kastein
Berlin, 12247, Germany
ATURO
Berlin, 14197, Germany
MVZ Burgdorf
Burgdorf, Hanover, 31303, Germany
Ev.-Luth. Diakonissenanstalt Dresden
Dresden, 01099, Germany
Stefan Carl
Emmendingen, 79312, Germany
Zentrum für Urologie FFM
Frankfurt, 60439, Germany
Georg-August-Universität Göttingen
Göttingen, 37075, Germany
Universitätsklinikum Halle (Saale)
Halle, 06120, Germany
Urologikum Hamburg
Hamburg, 22081, Germany
Urologische Praxis Volksdorf
Hamburg, 22359, Germany
Claudia Olszak-Warnat
Herne, 44649, Germany
Westpfalz-Klinikum Kaiserslautern
Kaiserslautern, 67655, Germany
Urologie Zentrum Kiel
Kiel, 24103, Germany
Joachim Weiß
Lampertheim, 68623, Germany
Uro- Vital-Zentrum, GP Hellmeier, Krause et al
Landshut, 84028, Germany
Tom Kempe
Leipzig, 04109, Germany
Institut Dr. Schulze
Markkleeberg, 04416, Germany
Elke Stagge
Mülheim, 45468, Germany
Universitätsklinikum Münster
Münster, 48149, Germany
Urologen am Stadtpark
Nuremberg, 90409, Germany
Urologicum Osnabrück
Osnabrück, 49076, Germany
Simone Maier
Reutlingen, 72764, Germany
Andres Melchior
Salzatal OT Schiepzig, 06198, Germany
Andreas Reinhard Wicht
Sangerhausen, 06526, Germany
Franz Hirschle
Singen, 78224, Germany
Wolfgang Theurer
Stuttgart, 70174, Germany
Benjamin Fischer
Tuttlingen, 78532, Germany
Dietmar Jung
Tuttlingen, 78532, Germany
Kontinenzzentrum Südwest
Villingen-Schwenningen, 78052, Germany
Hospital Universitario Burgos
Burgos, 09006, Spain
Hospital de Cabueñes
Gijón, 33394, Spain
Hospital Virgen de la Victoria
Málaga, 29010, Spain
Complejo Hospitalario Universitario Ourense
Ourense, 32005, Spain
Hospital Universitario Central de Asturias
Oviedo, 33011, Spain
Hospital Universitario Salamanca
Salamanca, 37007, Spain
Hospital Universitario Marqués de Valdecilla
Santander, 39008, Spain
Hospital Universitario Virgen del Rocío
Seville, 41013, Spain
Hospital de Valme
Seville, 41014, Spain
Urologimottagningen, Hallands Sjukhus Halmstad
Halmstad, 30185, Sweden
Urologiska kliniken, Södersjukhuset AB
Stockholm, 11883, Sweden
Karolinska Hospital
Stockholm, 17177, Sweden
Karolinska Hospital
Stockholm, 18288, Sweden
Kvinnokliniken, Danderyds Sjukhus AB
Stockholm, 18288, Sweden
Kirurgkliniken, Västervik Sjukhus
Västervik/Kalmar, 59381, Sweden
Queen Elizabeth Hospital, Queen Elizabeth Medical Centre, Edgbaston
Birmingham, B15 2TH, United Kingdom
Southern General Hospital
Glasgow, Lanarkshire, G51 4TF, United Kingdom
Leeds Teaching Hospitals NHS Trust, St. James's University Hospital
Leeds, West Yorkshire, LS9 7TF, United Kingdom
University College London Hospitals NHS foundation Trust
London, NW1 2BU, United Kingdom
Imperial College Healthcare NHS Trust, The Bays, St Mary's Hospital
London, W2 1NY, United Kingdom
St Helens & Knowsley Teaching Hospitals NHS Trust, Whiston Hospital
Prescot, Merseyside, L35 5DR, United Kingdom
Salisbury NHS Foundation Trust, Salisbury District Hospital
Salisbury, Wiltshire, SP2 8BJ, United Kingdom
Related Publications (4)
Farrelly E, Hamid R, Lorenzo-Gomez MF, Schulte-Baukloh H, Yu J, Patel A, Nelson M. One treatment with onabotulinumtoxinA relieves symptoms of overactive bladder in patients refractory to one or more oral medications. Neurourol Urodyn. 2023 Aug;42(6):1203-1213. doi: 10.1002/nau.25221. Epub 2023 Jun 1.
PMID: 37260130DERIVEDPoster. Female Pelvic Med Reconstr Surg. 2020 Oct 1;26(10S Suppl 1):S89-S189. doi: 10.1097/SPV.0000000000000936. No abstract available.
PMID: 33955921DERIVEDShort orals. Female Pelvic Med Reconstr Surg. 2020 Oct 1;26(10S Suppl 1):S21-S77. doi: 10.1097/SPV.0000000000000934. No abstract available.
PMID: 33955918DERIVEDHamid R, Lorenzo-Gomez MF, Schulte-Baukloh H, Boroujerdi A, Patel A, Farrelly E. OnabotulinumtoxinA is a well tolerated and effective treatment for refractory overactive bladder in real-world practice. Int Urogynecol J. 2021 Jan;32(1):65-74. doi: 10.1007/s00192-020-04423-0. Epub 2020 Jul 27.
PMID: 32719964DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2014
First Posted
June 11, 2014
Study Start
June 1, 2014
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
April 18, 2016
Record last verified: 2016-04