Clinical trial NCT02161159: An Observational Study of BOTOX® for the Management of Urinary Incontinence in Patients With Idiopathic Overactive Bladder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence
Urinary Bladder, Overactive
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-06-11
Enrollment: 515
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients With Urinary Incontinence Due to iOAB

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Patients Who have Greatly Improved or Improved on the 4-Point Treatment Benefit Scale (TBS)
timeFrame: Baseline, Week 12
measure: Change From Baseline in Number of Urinary Incontinence Episodes
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Time to Re-Injection of BOTOX®
timeFrame: 12 Months
measure: Number of Nocturia Episodes
timeFrame: 12 Months
measure: Usage of Incontinence Support Products
timeFrame: 12 Months
measure: Percentage of Patients Who Have at Least a 50% Reduction in Urinary Incontinence and Urinary Urgency Incontinence
timeFrame: Baseline, 12 Months
Other outcomes:
Locations:
city: Bad Mergentheim
country: Germany
facility: David Brix
city: Berlin
country: Germany
facility: Urologie Turmschtraße
city: Berlin
country: Germany
facility: Uwe-Carsten
city: Berlin
country: Germany
facility: Albrecht Kastein
city: Berlin
country: Germany
facility: ATURO
city: Burgdorf
country: Germany
facility: MVZ Burgdorf
city: Dresden
country: Germany
facility: Ev.-Luth. Diakonissenanstalt Dresden
city: Emmendingen
country: Germany
facility: Stefan Carl
city: Frankfurt
country: Germany
facility: Zentrum für Urologie FFM
city: Göttingen
country: Germany
facility: Georg-August-Universität Göttingen
city: Halle (Saale)
country: Germany
facility: Universitätsklinikum Halle (Saale)
city: Hamburg
country: Germany
facility: Urologikum Hamburg
city: Hamburg
country: Germany
facility: Urologische Praxis Volksdorf
city: Herne
country: Germany
facility: Claudia Olszak-Warnat
city: Kaiserslautern
country: Germany
facility: Westpfalz-Klinikum Kaiserslautern
city: Kiel
country: Germany
facility: Urologie Zentrum Kiel
city: Lampertheim
country: Germany
facility: Joachim Weiß
city: Landshut
country: Germany
facility: Uro- Vital-Zentrum, GP Hellmeier, Krause et al
city: Leipzig
country: Germany
facility: Tom Kempe
city: Markkleeberg
country: Germany
facility: Institut Dr. Schulze
city: Mülheim
country: Germany
facility: Elke Stagge
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Nürnberg
country: Germany
facility: Urologen am Stadtpark
city: Osnabrück
country: Germany
facility: Urologicum Osnabrück
city: Reutlingen
country: Germany
facility: Simone Maier
city: Salzatal OT Schiepzig
country: Germany
facility: Andres Melchior
city: Sangerhausen
country: Germany
facility: Andreas Reinhard Wicht
city: Singen
country: Germany
facility: Franz Hirschle
city: Stuttgart
country: Germany
facility: Wolfgang Theurer
city: Tuttlingen
country: Germany
facility: Benjamin Fischer
city: Tuttlingen
country: Germany
facility: Dietmar Jung
city: Villingen-Schwenningen
country: Germany
facility: Kontinenzzentrum Südwest
city: Burgos
country: Spain
facility: Hospital Universitario Burgos
city: Gijón
country: Spain
facility: Hospital de Cabueñes
city: Málaga
country: Spain
facility: Hospital Virgen de la Victoria
city: Ourense
country: Spain
facility: Complejo Hospitalario Universitario Ourense
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Salamanca
country: Spain
facility: Hospital Universitario Salamanca
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Sevilla
country: Spain
facility: Hospital de Valme
city: Halmstad
country: Sweden
facility: Urologimottagningen, Hallands Sjukhus Halmstad
city: Stockholm
country: Sweden
facility: Urologiska kliniken, Södersjukhuset AB
city: Stockholm
country: Sweden
facility: Karolinska Hospital
city: Stockholm
country: Sweden
facility: Karolinska Hospital
city: Stockholm
country: Sweden
facility: Kvinnokliniken, Danderyds Sjukhus AB
city: Västervik/Kalmar
country: Sweden
facility: Kirurgkliniken, Västervik Sjukhus
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital, Queen Elizabeth Medical Centre, Edgbaston
city: Glasgow, Lanarkshire
country: United Kingdom
facility: Southern General Hospital
city: Leeds, West Yorkshire
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust, St. James's University Hospital
city: London
country: United Kingdom
facility: University College London Hospitals NHS foundation Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust, The Bays, St Mary's Hospital
city: Prescot, Merseyside
country: United Kingdom
facility: St Helens & Knowsley Teaching Hospitals NHS Trust, Whiston Hospital
city: Salisbury, Wiltshire
country: United Kingdom
facility: Salisbury NHS Foundation Trust, Salisbury District Hospital
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Poster. Female Pelvic Med Reconstr Surg. 2020 Oct 1;26(10S Suppl 1):S89-S189. doi: 10.1097/SPV.0000000000000936. No abstract available.
citation: Short orals. Female Pelvic Med Reconstr Surg. 2020 Oct 1;26(10S Suppl 1):S21-S77. doi: 10.1097/SPV.0000000000000934. No abstract available.
citation: 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.