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

NCT ID: NCT02161159

Last Updated: 2016-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

515 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Urinary Incontinence Urinary Bladder, Overactive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients With Urinary Incontinence Due to iOAB

Patients with urinary incontinence due to iOAB treated with BOTOX® in accordance with physician standard practice.

botulinum toxin Type A

Intervention Type BIOLOGICAL

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

Interventions

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botulinum toxin Type A

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

Intervention Type BIOLOGICAL

Other Intervention Names

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BOTOX® onabotulinumtoxinA

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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David Brix

Bad Mergentheim, , Germany

Site Status

Urologie Turmschtraße

Berlin, , Germany

Site Status

Uwe-Carsten

Berlin, , Germany

Site Status

Albrecht Kastein

Berlin, , Germany

Site Status

ATURO

Berlin, , Germany

Site Status

MVZ Burgdorf

Burgdorf, Hanover, , Germany

Site Status

Ev.-Luth. Diakonissenanstalt Dresden

Dresden, , Germany

Site Status

Stefan Carl

Emmendingen, , Germany

Site Status

Zentrum für Urologie FFM

Frankfurt, , Germany

Site Status

Georg-August-Universität Göttingen

Göttingen, , Germany

Site Status

Universitätsklinikum Halle (Saale)

Halle, , Germany

Site Status

Urologikum Hamburg

Hamburg, , Germany

Site Status

Urologische Praxis Volksdorf

Hamburg, , Germany

Site Status

Claudia Olszak-Warnat

Herne, , Germany

Site Status

Westpfalz-Klinikum Kaiserslautern

Kaiserslautern, , Germany

Site Status

Urologie Zentrum Kiel

Kiel, , Germany

Site Status

Joachim Weiß

Lampertheim, , Germany

Site Status

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

Landshut, , Germany

Site Status

Tom Kempe

Leipzig, , Germany

Site Status

Institut Dr. Schulze

Markkleeberg, , Germany

Site Status

Elke Stagge

Mülheim, , Germany

Site Status

Universitätsklinikum Münster

Münster, , Germany

Site Status

Urologen am Stadtpark

Nuremberg, , Germany

Site Status

Urologicum Osnabrück

Osnabrück, , Germany

Site Status

Simone Maier

Reutlingen, , Germany

Site Status

Andres Melchior

Salzatal OT Schiepzig, , Germany

Site Status

Andreas Reinhard Wicht

Sangerhausen, , Germany

Site Status

Franz Hirschle

Singen, , Germany

Site Status

Wolfgang Theurer

Stuttgart, , Germany

Site Status

Benjamin Fischer

Tuttlingen, , Germany

Site Status

Dietmar Jung

Tuttlingen, , Germany

Site Status

Kontinenzzentrum Südwest

Villingen-Schwenningen, , Germany

Site Status

Hospital Universitario Burgos

Burgos, , Spain

Site Status

Hospital de Cabueñes

Gijón, , Spain

Site Status

Hospital Virgen de la Victoria

Málaga, , Spain

Site Status

Complejo Hospitalario Universitario Ourense

Ourense, , Spain

Site Status

Hospital Universitario Central de Asturias

Oviedo, , Spain

Site Status

Hospital Universitario Salamanca

Salamanca, , Spain

Site Status

Hospital Universitario Marqués de Valdecilla

Santander, , Spain

Site Status

Hospital Universitario Virgen del Rocío

Seville, , Spain

Site Status

Hospital de Valme

Seville, , Spain

Site Status

Urologimottagningen, Hallands Sjukhus Halmstad

Halmstad, , Sweden

Site Status

Urologiska kliniken, Södersjukhuset AB

Stockholm, , Sweden

Site Status

Karolinska Hospital

Stockholm, , Sweden

Site Status

Karolinska Hospital

Stockholm, , Sweden

Site Status

Kvinnokliniken, Danderyds Sjukhus AB

Stockholm, , Sweden

Site Status

Kirurgkliniken, Västervik Sjukhus

Västervik/Kalmar, , Sweden

Site Status

Queen Elizabeth Hospital, Queen Elizabeth Medical Centre, Edgbaston

Birmingham, , United Kingdom

Site Status

Southern General Hospital

Glasgow, Lanarkshire, , United Kingdom

Site Status

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

Leeds, West Yorkshire, , United Kingdom

Site Status

University College London Hospitals NHS foundation Trust

London, , United Kingdom

Site Status

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

London, , United Kingdom

Site Status

St Helens & Knowsley Teaching Hospitals NHS Trust, Whiston Hospital

Prescot, Merseyside, , United Kingdom

Site Status

Salisbury NHS Foundation Trust, Salisbury District Hospital

Salisbury, Wiltshire, , United Kingdom

Site Status

Countries

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Germany Spain Sweden United Kingdom

References

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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.

Reference Type DERIVED
PMID: 37260130 (View on PubMed)

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

Reference Type DERIVED
PMID: 33955921 (View on PubMed)

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

Reference Type DERIVED
PMID: 33955918 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32719964 (View on PubMed)

Other Identifiers

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MAF/AGN/NS/OAB/002

Identifier Type: -

Identifier Source: org_study_id

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