Efficacy and Safety Study of Botulinum Toxin Type-A (Dysport®) in Continent Female Subjects Suffering From Idiopathic Overactive Bladder
NCT ID: NCT00578097
Last Updated: 2019-11-22
Study Results
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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TERMINATED
PHASE2
81 participants
INTERVENTIONAL
2008-02-29
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A - 125 units
Botulinum toxin type A
Single injection cycle, intradetrusor injection at baseline visit 2 of either 125 units (arm A), 250 units (arm B) or 500 units (arm C) in total.
B - 250 units
Botulinum toxin type A
Single injection cycle, intradetrusor injection at baseline visit 2 of either 125 units (arm A), 250 units (arm B) or 500 units (arm C) in total.
C - 500 units
Botulinum toxin type A
Single injection cycle, intradetrusor injection at baseline visit 2 of either 125 units (arm A), 250 units (arm B) or 500 units (arm C) in total.
D
Placebo
Single injection cycle, intradetrusor injection at baseline (visit 2).
Interventions
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Botulinum toxin type A
Single injection cycle, intradetrusor injection at baseline visit 2 of either 125 units (arm A), 250 units (arm B) or 500 units (arm C) in total.
Placebo
Single injection cycle, intradetrusor injection at baseline (visit 2).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The subject has ≥ 3 urgency episodes over the course of the 3 days immediately preceding the Baseline visit.
* The subject has ≥ 24 episodes of micturition over the course of the 3 days immediately preceding the Baseline visit.
Exclusion Criteria
* Post-Micturition Residual Volume \> 150 ml (ultrasound assessment).
* Evidence of a urinary tract infection at Screening or Baseline in the study.
* Active or history of interstitial cystitis, malignancy of the bladder or urothelial tract, a carcinoma in situ (non malignant melanoma is allowed) bladder and/or kidney stones.
18 Years
75 Years
FEMALE
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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ULB Hôpital Erasme
Brussels, , Belgium
CH Régional Huy - Polyclinique A Rue Trois Ponts
Huy, , Belgium
UZ Gasthuisberg
Leuven, , Belgium
CHU Liege Sart Tilman
Liège, , Belgium
Urologická klinika
Olomouc, , Czechia
Urologické oddělení
Prague, , Czechia
Hôpital Michallon - CHU de Grenoble
Grenoble, , France
Groupe Hospitalier Pitié-Salpétrière
Paris, , France
Hôpital Charles Nicolle - CHU de Rouen
Rouen, , France
Hôpital Henri Gabrielle - Hôpitaux Civils de Lyon
Saint-Genis-Laval, , France
Hôpital Rangueil - CHU de Toulouse
Toulouse, , France
Medizinische Einrichtungen der RWTH
Aachen, , Germany
Praxis für Urologie
Bad Kreuznach, , Germany
Praxis für Urologie
Emmendingen, , Germany
Praxis für Urologie
Günzburg, , Germany
Praxis für Urologie
Lahr, , Germany
Beckenboden Zentrum München
München, , Germany
Städtisches Klinikum Neunkirchen gGmbH
Neunkirchen, , Germany
Krankenhaus St. Trudpert
Pforzheim, , Germany
Unità Spinale, Azienda Ospedaliera Careggi
Florence, , Italy
Unità Spinale, Ospedale Niguarda
Milan, , Italy
Struttura Complessa di Neuro-Urologia
Torino, , Italy
General Urology Academisch Ziekenhuis Maastricht
Maastricht, P.Debyelaan 25, Netherlands
VU Medisch Centrum Amsterdam
Amsterdam, , Netherlands
UMC St. Radboud
Nijmegen, , Netherlands
Erasmus MC, Universitair Medisch Centrum Rotterdam
Rotterdam, , Netherlands
Hospital San Rafael
Madrid, , Spain
Hospital Clínico Universitario Canarias
San Cristóbal de La Laguna, , Spain
Hospital Universitario La Fe
Valencia, , Spain
Southmead Hospital
Bristol, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
St George's Hospital
London, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
Royal Berkshire Hospital
Reading, , United Kingdom
Countries
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Other Identifiers
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2007-002999-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Y-79-52120-126
Identifier Type: -
Identifier Source: org_study_id
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