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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-002999-34 | EudraCT Number |
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The study was terminated early due to poor recruitment.
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The purpose of this study is to determine the optimal dose of botulinum toxin type A injected in the detrusor muscle to improve urinary symptoms, urodynamic parameters and quality of life of continent women suffering from idiopathic overactive bladder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A - 125 units | Experimental |
| |
| B - 250 units | Experimental |
| |
| C - 500 units | Experimental |
| |
| D | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of episodes of urgency and frequency of micturition. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| The number of episodes of urgency, frequency of micturition, and frequency of nocturia. | All timepoints | |
| Severity of urgency. | All timepoints | |
| Maximum flow rate and post-micturition residual volume (PMRV). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ULB Hôpital Erasme | Brussels | B-1070 | Belgium | |||
| CH Régional Huy - Polyclinique A Rue Trois Ponts |
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|
| Placebo | Drug | Single injection cycle, intradetrusor injection at baseline (visit 2). |
|
| Day 4 and Week 6 |
| Standard International Continence Society (ICS) urodynamic parameters. | Week 12 |
| Quality of Life (QoL). | All timepoints |
| Safety | All timepoints |
| Extension study - Duration of effect as determined by the persistence of a positive response. | All timepoints |
| Extension study - The number of episodes of urgency, frequency of micturition, and frequency of nocturia. | All timepoints |
| Extension study - Severity of urgency. | All timepoints |
| Extension study Quality of Life (QoL) | All timepoints |
| Extension study safety. | All timepoints |
| Huy |
| 2 4500 |
| Belgium |
| UZ Gasthuisberg | Leuven | 3000 | Belgium |
| CHU Liege Sart Tilman | Liège | Belgium |
| Urologická klinika | Olomouc | 775 20 | Czechia |
| Urologické oddělení | Prague | 140 00 | Czechia |
| Hôpital Michallon - CHU de Grenoble | Grenoble | 38043 | France |
| Groupe Hospitalier Pitié-Salpétrière | Paris | 75661 | France |
| Hôpital Charles Nicolle - CHU de Rouen | Rouen | 76031 | France |
| Hôpital Henri Gabrielle - Hôpitaux Civils de Lyon | Saint-Genis-Laval | 69230 | France |
| Hôpital Rangueil - CHU de Toulouse | Toulouse | 31059 | France |
| Medizinische Einrichtungen der RWTH | Aachen | 52074 | Germany |
| Praxis für Urologie | Bad Kreuznach | 55543 | Germany |
| Praxis für Urologie | Emmendingen | 79312 | Germany |
| Praxis für Urologie | Günzburg | 89312 | Germany |
| Praxis für Urologie | Lahr | 77933 | Germany |
| Beckenboden Zentrum München | München | 81679 | Germany |
| Städtisches Klinikum Neunkirchen gGmbH | Neunkirchen | 66538 | Germany |
| Krankenhaus St. Trudpert | Pforzheim | 75177 | Germany |
| Unità Spinale, Azienda Ospedaliera Careggi | Florence | 50139 | Italy |
| Unità Spinale, Ospedale Niguarda | Milan | 20100 | Italy |
| Struttura Complessa di Neuro-Urologia | Torino | 1053 | Italy |
| General Urology Academisch Ziekenhuis Maastricht | Maastricht | P.Debyelaan 25 | 6229 HX | Netherlands |
| VU Medisch Centrum Amsterdam | Amsterdam | 1081 HV | Netherlands |
| UMC St. Radboud | Nijmegen | 6525 GA | Netherlands |
| Erasmus MC, Universitair Medisch Centrum Rotterdam | Rotterdam | 3000 CA | Netherlands |
| Hospital San Rafael | Madrid | 28016 | Spain |
| Hospital Clínico Universitario Canarias | San Cristóbal de La Laguna | 38330 | Spain |
| Hospital Universitario La Fe | Valencia | 46009 | Spain |
| Southmead Hospital | Bristol | BS10 5NB | United Kingdom |
| Western General Hospital | Edinburgh | EH4 2XU | United Kingdom |
| St George's Hospital | London | SW17 OQT | United Kingdom |
| Churchill Hospital | Oxford | OX3 7LJ | United Kingdom |
| Royal Berkshire Hospital | Reading | RG1 5AN | United Kingdom |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C542869 | abobotulinumtoxinA |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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