Efficacy and Safety Study of Botulinum Toxin Type-A (Dysport®) in Continent Female Subjects Suffering From Idiopathic Overactive Bladder - Full Text View

Sponsor:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00578097

Purpose

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.

Condition	Intervention	Phase
Overactive Bladder	Drug: Botulinum type A (Dysport®) Other: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase II, International, Multi-centre, Prospective, Randomised, Parallel-group, Double-blind, Dose-ranging, Placebo-controlled, 12-week, Study to Assess the Efficacy and Safety of a One Injection Cycle With Either Botulinum Toxin Type-A (Dysport® 125, 250 or 500 Units) or Placebo Followed by an Optional 6-month Extension Phase in the Symptomatic Treatment of Micturition Urgency and Frequency in Continent Female Subjects Suffering From Idiopathic Overactive Bladder.

Resource links provided by NLM:

MedlinePlus related topics: Botox Urine and Urination

Drug Information available for: Clostridium botulinum toxin

U.S. FDA Resources

Further study details as provided by Ipsen:

Primary Outcome Measures:

Number of episodes of urgency and frequency of micturition. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The number of episodes of urgency, frequency of micturition, and frequency of nocturia. [ Time Frame: All timepoints ] [ Designated as safety issue: No ]
Severity of urgency. [ Time Frame: All timepoints ] [ Designated as safety issue: No ]
Maximum flow rate and post-micturition residual volume (PMRV). [ Time Frame: Day 4 and Week 6 ] [ Designated as safety issue: No ]
Standard International Continence Society (ICS) urodynamic parameters. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Quality of Life (QoL). [ Time Frame: All timepoints ] [ Designated as safety issue: No ]
Safety [ Time Frame: All timepoints ] [ Designated as safety issue: Yes ]
Extension study - Duration of effect as determined by the persistence of a positive response. [ Time Frame: All timepoints ] [ Designated as safety issue: No ]
Extension study - The number of episodes of urgency, frequency of micturition, and frequency of nocturia. [ Time Frame: All timepoints ] [ Designated as safety issue: No ]
Extension study - Severity of urgency. [ Time Frame: All timepoints ] [ Designated as safety issue: No ]
Extension study Quality of Life (QoL) [ Time Frame: All timepoints ] [ Designated as safety issue: No ]
Extension study safety. [ Time Frame: All timepoints ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	80
Study Start Date:	February 2008
Estimated Study Completion Date:	December 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A - 125 units: Experimental	Drug: Botulinum type A (Dysport®) 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: Experimental	Drug: Botulinum type A (Dysport®) 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: Experimental	Drug: Botulinum type A (Dysport®) 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 Comparator	Other: Placebo Single injection cycle, intradetrusor injection at baseline (visit 2).

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The subject has a diagnosis of idiopathic overactive bladder, without incontinence.
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:

Bladder outlet obstruction (on urodynamic assessment).
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00578097

Locations

Belgium
UZ Gasthuisberg
Leuven, Belgium, 3000
CH Régional Huy - Polyclinique A Rue Trois Ponts
Huy, Belgium, 2 4500
ULB Hôpital Erasme
Brussels, Belgium, B-1070
CHU Liege Sart Tilman
Liege, Belgium
Czech Republic
Urologické oddělení
Praha 4, Czech Republic, 140 00
Urologická klinika
Olomouc, Czech Republic, 775 20
France
Hôpital Charles Nicolle - CHU de Rouen
Rouen Cedex, France, 76031
Hôpital Henri Gabrielle - Hôpitaux Civils de Lyon
Saint Genis Laval, France, 69230
Hôpital Michallon - CHU de Grenoble
Grenoble Cedex, France, 38043
Hôpital Rangueil - CHU de Toulouse
Toulouse, France, 31059
Groupe Hospitalier Pitié-Salpétrière
Paris Cedex 16, France, 75661
Germany
Praxis für Urologie
Emmendingen, Germany, 79312
Städtisches Klinikum Neunkirchen gGmbH
Neunkirchen, Germany, 66538
Beckenboden Zentrum München
München, Germany, 81679
Medizinische Einrichtungen der RWTH
Aachen, Germany, 52074
Praxis für Urologie
Bad Kreuznach, Germany, 55543
Praxis für Urologie
Lahr, Germany, 77933
Krankenhaus St. Trudpert
Pforzheim, Germany, 75177
Praxis für Urologie
Günzburg, Germany, 89312
Italy
Unità Spinale, Ospedale Niguarda
Milano, Italy, 20100
Unità Spinale, Azienda Ospedaliera Careggi
Firenze, Italy, 50139
Struttura Complessa di Neuro-Urologia
Torino, Italy, 1053
Netherlands
General Urology Academisch Ziekenhuis Maastricht
Maastricht, Netherlands
UMC St. Radboud
Nijmegen, Netherlands, 6525 GA
Erasmus MC, Universitair Medisch Centrum Rotterdam
Rotterdam, Netherlands, 3000 CA
VU Medisch Centrum Amsterdam
Amsterdam, Netherlands, 1081 HV
Spain
Hospital San Rafael
Madrid, Spain, 28016
Hospital Clínico Universitario Canarias
La Laguna, Spain, 38330
Hospital Universitario La Fe
Valencia, Spain, 46009
United Kingdom
Churchill Hospital
Oxford, United Kingdom, OX3 7LJ
St George's Hospital
London, United Kingdom, SW17 OQT
Southmead Hospital
Bristol, United Kingdom, BS10 5NB
Royal Berkshire Hospital
Reading, United Kingdom, RG1 5AN
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU

Sponsors and Collaborators

Ipsen

Investigators

Study Director:

Benjamin Zakine, MD

Ipsen

More Information

No publications provided

Responsible Party:	Ipsen ( Benjamin Zakine )
Study ID Numbers:	Y-79-52120-126
Study First Received:	December 18, 2007
Last Updated:	October 20, 2009
ClinicalTrials.gov Identifier:	NCT00578097 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Germany: Federal Institute for Drugs and Medical Devices; Czech Republic: State Institute for Drug Control; Belgium: Federal Agency for Medicinal Products and Health Products; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Italy: The Italian Medicines Agency; Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:

Urinary Bladder, Overactive
Anti-Dyskinesia Agents
Urinary Bladder Diseases
Physiological Effects of Drugs
Neuromuscular Agents
Pharmacologic Actions
Urological Manifestations

Signs and Symptoms
Botulinum Toxins
Urologic Diseases
Therapeutic Uses
Peripheral Nervous System Agents
Botulinum Toxin Type A
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010