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

Completed

• Conditions: Urinary Incontinence; Urinary Bladder, Overactive
• Interventions: Biological: botulinum toxin Type A

• Registration Number: NCT02161159
• Lead Sponsor: Allergan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-09
• Study First Submitted QC: 2014-06-09
• Study First Posted: 2014-06-11
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-14
• Last Update Posted: 2016-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 515

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients With Urinary Incontinence Due to iOAB	botulinum toxin Type A	Patients with urinary incontinence due to iOAB treated with BOTOX® in accordance with physician standard practice.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (53)

Andreas Reinhard Wicht; 🇩🇪 Sangerhausen, Germany

Franz Hirschle; 🇩🇪 Singen, Germany

Universitätsklinikum Münster; 🇩🇪 Münster, Germany

Hospital Universitario Burgos; 🇪🇸 Burgos, Spain

University College London Hospitals NHS foundation Trust; 🇬🇧 London, United Kingdom

St Helens & Knowsley Teaching Hospitals NHS Trust, Whiston Hospital; 🇬🇧 Prescot, Merseyside, United Kingdom

Salisbury NHS Foundation Trust, Salisbury District Hospital; 🇬🇧 Salisbury, Wiltshire, United Kingdom

Urologie Turmschtraße; 🇩🇪 Berlin, Germany

David Brix; 🇩🇪 Bad Mergentheim, Germany

Uwe-Carsten; 🇩🇪 Berlin, Germany

ATURO; 🇩🇪 Berlin, Germany

MVZ Burgdorf; 🇩🇪 Burgdorf, Germany

Ev.-Luth. Diakonissenanstalt Dresden; 🇩🇪 Dresden, Germany

Stefan Carl; 🇩🇪 Emmendingen, Germany

Zentrum für Urologie FFM; 🇩🇪 Frankfurt, Germany

Urologen am Stadtpark; 🇩🇪 Nürnberg, Germany

Urologie Zentrum Kiel; 🇩🇪 Kiel, Germany

Elke Stagge; 🇩🇪 Mülheim, Germany

Urologikum Hamburg; 🇩🇪 Hamburg, Germany

Tom Kempe; 🇩🇪 Leipzig, Germany

Urologische Praxis Volksdorf; 🇩🇪 Hamburg, Germany

Westpfalz-Klinikum Kaiserslautern; 🇩🇪 Kaiserslautern, Germany

Claudia Olszak-Warnat; 🇩🇪 Herne, Germany

Wolfgang Theurer; 🇩🇪 Stuttgart, Germany

Uro- Vital-Zentrum, GP Hellmeier, Krause et al; 🇩🇪 Landshut, Germany

Joachim Weiß; 🇩🇪 Lampertheim, Germany

Kontinenzzentrum Südwest; 🇩🇪 Villingen-Schwenningen, Germany

Hospital Virgen de la Victoria; 🇪🇸 Málaga, Spain

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Spain

Institut Dr. Schulze; 🇩🇪 Markkleeberg, Germany

Hospital Universitario Salamanca; 🇪🇸 Salamanca, Spain

Hospital Universitario Marqués de Valdecilla; 🇪🇸 Santander, Spain

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Spain

Simone Maier; 🇩🇪 Reutlingen, Germany

Hospital de Cabueñes; 🇪🇸 Gijón, Spain

Complejo Hospitalario Universitario Ourense; 🇪🇸 Ourense, Spain

Urologicum Osnabrück; 🇩🇪 Osnabrück, Germany

Hospital de Valme; 🇪🇸 Sevilla, Spain

Urologimottagningen, Hallands Sjukhus Halmstad; 🇸🇪 Halmstad, Sweden

Kvinnokliniken, Danderyds Sjukhus AB; 🇸🇪 Stockholm, Sweden

Queen Elizabeth Hospital, Queen Elizabeth Medical Centre, Edgbaston; 🇬🇧 Birmingham, United Kingdom

Urologiska kliniken, Södersjukhuset AB; 🇸🇪 Stockholm, Sweden

Karolinska Hospital; 🇸🇪 Stockholm, Sweden

Kirurgkliniken, Västervik Sjukhus; 🇸🇪 Västervik/Kalmar, Sweden

Southern General Hospital; 🇬🇧 Glasgow, Lanarkshire, United Kingdom

Imperial College Healthcare NHS Trust, The Bays, St Mary's Hospital; 🇬🇧 London, United Kingdom

Leeds Teaching Hospitals NHS Trust, St. James's University Hospital; 🇬🇧 Leeds, West Yorkshire, United Kingdom

Universitätsklinikum Halle (Saale); 🇩🇪 Halle (Saale), Germany

Albrecht Kastein; 🇩🇪 Berlin, Germany

Georg-August-Universität Göttingen; 🇩🇪 Göttingen, Germany

Andres Melchior; 🇩🇪 Salzatal OT Schiepzig, Germany

Benjamin Fischer; 🇩🇪 Tuttlingen, Germany

Dietmar Jung; 🇩🇪 Tuttlingen, Germany