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AzTrials

Urinary IncontinenceGRACENCT02161159

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

An observational study of Urinary Incontinence and Urinary Bladder, Overactive, run by Allergan at 54 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
botulinum toxin Type A
How many people
515 participants
Where
54 sitesin 4 countries
Study dates
Jun 2014to Jan 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients With Urinary Incontinence Due to iOAB

Who may be able to join

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

Who cannot join

  • Treatment with any botulinum toxin Type A within 18 months

Trial locations and contacts

54 sites in 4 countries.

54 sites in 4 countries

Germany32 sites

  • David Brix

    Bad Mergentheim, 97980

  • Urologie Turmschtraße

    Berlin, 10551

  • Uwe-Carsten

    Berlin, 12099

  • Albrecht Kastein

    Berlin, 12247

  • ATURO

    Berlin, 14197

  • MVZ Burgdorf

    Burgdorf, Hanover, 31303

  • Ev.-Luth. Diakonissenanstalt Dresden

    Dresden, 01099

  • Stefan Carl

    Emmendingen, 79312

  • Zentrum für Urologie FFM

    Frankfurt, 60439

  • Georg-August-Universität Göttingen

    Göttingen, 37075

  • Universitätsklinikum Halle (Saale)

    Halle, 06120

  • Urologikum Hamburg

    Hamburg, 22081

  • Urologische Praxis Volksdorf

    Hamburg, 22359

  • Claudia Olszak-Warnat

    Herne, 44649

  • Westpfalz-Klinikum Kaiserslautern

    Kaiserslautern, 67655

  • Urologie Zentrum Kiel

    Kiel, 24103

  • Joachim Weiß

    Lampertheim, 68623

  • Uro- Vital-Zentrum, GP Hellmeier, Krause et al

    Landshut, 84028

  • Tom Kempe

    Leipzig, 04109

  • Institut Dr. Schulze

    Markkleeberg, 04416

  • Elke Stagge

    Mülheim, 45468

  • Universitätsklinikum Münster

    Münster, 48149

  • Urologen am Stadtpark

    Nuremberg, 90409

  • Urologicum Osnabrück

    Osnabrück, 49076

  • Simone Maier

    Reutlingen, 72764

  • Andres Melchior

    Salzatal OT Schiepzig, 06198

  • Andreas Reinhard Wicht

    Sangerhausen, 06526

  • Franz Hirschle

    Singen, 78224

  • Wolfgang Theurer

    Stuttgart, 70174

  • Benjamin Fischer

    Tuttlingen, 78532

  • Dietmar Jung

    Tuttlingen, 78532

  • Kontinenzzentrum Südwest

    Villingen-Schwenningen, 78052

Other trials in Germany

Spain9 sites

  • Hospital Universitario Burgos

    Burgos, 09006

  • Hospital de Cabueñes

    Gijón, 33394

  • Hospital Virgen de la Victoria

    Málaga, 29010

  • Complejo Hospitalario Universitario Ourense

    Ourense, 32005

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

  • Hospital Universitario Salamanca

    Salamanca, 37007

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

  • Hospital de Valme

    Seville, 41014

Other trials in Spain

United Kingdom7 sites

  • Queen Elizabeth Hospital, Queen Elizabeth Medical Centre, Edgbaston

    Birmingham, B15 2TH

  • Southern General Hospital

    Glasgow, Lanarkshire, G51 4TF

  • Leeds Teaching Hospitals NHS Trust, St. James's University Hospital

    Leeds, West Yorkshire, LS9 7TF

  • University College London Hospitals NHS foundation Trust

    London, NW1 2BU

  • Imperial College Healthcare NHS Trust, The Bays, St Mary's Hospital

    London, W2 1NY

  • St Helens & Knowsley Teaching Hospitals NHS Trust, Whiston Hospital

    Prescot, Merseyside, L35 5DR

  • Salisbury NHS Foundation Trust, Salisbury District Hospital

    Salisbury, Wiltshire, SP2 8BJ

Other trials in United Kingdom

Sweden6 sites

  • Urologimottagningen, Hallands Sjukhus Halmstad

    Halmstad, 30185

  • Urologiska kliniken, Södersjukhuset AB

    Stockholm, 11883

  • Karolinska Hospital

    Stockholm, 17177

  • Karolinska Hospital

    Stockholm, 18288

  • Kvinnokliniken, Danderyds Sjukhus AB

    Stockholm, 18288

  • Kirurgkliniken, Västervik Sjukhus

    Västervik/Kalmar, 59381

Other trials in Sweden

About this study

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.

Medical subject headings
Urinary Incontinence, Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • botulinum toxin Type ABiological

    Also called BOTOX®, onabotulinumtoxinA

    botulinum toxin Type A administered in accordance with physician standard practice.

Study groups in NCT02161159
Study groupRoleWhat they receive
Patients With Urinary Incontinence Due to iOABPatients with urinary incontinence due to iOAB treated with BOTOX® in accordance with physician standard practice.
Receives: Biological: botulinum toxin Type A

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Patients Who have Greatly Improved or Improved on the 4-Point Treatment Benefit Scale (TBS)

    Measured: Baseline, Week 12

  2. Change From Baseline in Number of Urinary Incontinence Episodes

    Measured: Baseline, Week 12

Secondary outcomes (4)

  1. Time to Re-Injection of BOTOX®

    Measured: 12 Months

  2. Number of Nocturia Episodes

    Measured: 12 Months

  3. Usage of Incontinence Support Products

    Measured: 12 Months

  4. Percentage of Patients Who Have at Least a 50% Reduction in Urinary Incontinence and Urinary Urgency Incontinence

    Measured: Baseline, 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
515 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02161159
Sponsor's protocol ID
MAF/AGN/NS/OAB/002
Acronym
GRACE
Status last verified
Apr 2016
First submitted
9 Jun 2014
Last updated
18 Apr 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 37260130

  • Poster. Female Pelvic Med Reconstr Surg. 2020 Oct 1;26(10S Suppl 1):S89-S189. doi: 10.1097/SPV.0000000000000936. No abstract available.

    PubMed 33955921

  • Short orals. Female Pelvic Med Reconstr Surg. 2020 Oct 1;26(10S Suppl 1):S21-S77. doi: 10.1097/SPV.0000000000000934. No abstract available.

    PubMed 33955918

  • Hamid 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.

    PubMed 32719964

Questions about this trial

What is this clinical trial studying?

An observational study of Urinary Incontinence and Urinary Bladder, Overactive, run by Allergan at 54 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in Germany, Spain, United Kingdom, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients Who have Greatly Improved or Improved on the 4-Point Treatment Benefit Scale (TBS) (time frame: Baseline, Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02161159, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2016.

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