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

This study has been terminated.
(The study was terminated early due to poor recruitment.)
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00578097
First received: December 18, 2007
Last updated: April 29, 2010
Last verified: April 2010
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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:


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 ]

Enrollment: 81
Study Start Date: February 2008
Study Completion Date: December 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A - 125 units 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.
Experimental: B - 250 units 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.
Experimental: C - 500 units 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.
Placebo Comparator: D 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Belgium
ULB Hôpital Erasme
Brussels, Belgium, B-1070
CH Régional Huy - Polyclinique A Rue Trois Ponts
Huy, Belgium, 2 4500
UZ Gasthuisberg
Leuven, Belgium, 3000
CHU Liege Sart Tilman
Liege, Belgium
Czech Republic
Urologická klinika
Olomouc, Czech Republic, 775 20
Urologické oddělení
Praha 4, Czech Republic, 140 00
France
Hôpital Michallon - CHU de Grenoble
Grenoble Cedex, France, 38043
Groupe Hospitalier Pitié-Salpétrière
Paris Cedex 16, France, 75661
Hôpital Charles Nicolle - CHU de Rouen
Rouen Cedex, France, 76031
Hôpital Henri Gabrielle - Hôpitaux Civils de Lyon
Saint Genis Laval, France, 69230
Hôpital Rangueil - CHU de Toulouse
Toulouse, France, 31059
Germany
Medizinische Einrichtungen der RWTH
Aachen, Germany, 52074
Praxis für Urologie
Bad Kreuznach, Germany, 55543
Praxis für Urologie
Emmendingen, Germany, 79312
Praxis für Urologie
Günzburg, Germany, 89312
Praxis für Urologie
Lahr, Germany, 77933
Beckenboden Zentrum München
München, Germany, 81679
Städtisches Klinikum Neunkirchen gGmbH
Neunkirchen, Germany, 66538
Krankenhaus St. Trudpert
Pforzheim, Germany, 75177
Italy
Unità Spinale, Azienda Ospedaliera Careggi
Firenze, Italy, 50139
Unità Spinale, Ospedale Niguarda
Milano, Italy, 20100
Struttura Complessa di Neuro-Urologia
Torino, Italy, 1053
Netherlands
General Urology Academisch Ziekenhuis Maastricht
Maastricht, P.Debyelaan 25, Netherlands, 6229 HX
VU Medisch Centrum Amsterdam
Amsterdam, Netherlands, 1081 HV
UMC St. Radboud
Nijmegen, Netherlands, 6525 GA
Erasmus MC, Universitair Medisch Centrum Rotterdam
Rotterdam, Netherlands, 3000 CA
Spain
Hospital Clínico Universitario Canarias
La Laguna, Spain, 38330
Hospital San Rafael
Madrid, Spain, 28016
Hospital Universitario La Fe
Valencia, Spain, 46009
United Kingdom
Southmead Hospital
Bristol, United Kingdom, BS10 5NB
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
St George's Hospital
London, United Kingdom, SW17 OQT
Churchill Hospital
Oxford, United Kingdom, OX3 7LJ
Royal Berkshire Hospital
Reading, United Kingdom, RG1 5AN
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Benjamin Zakine, MD Ipsen
  More Information

No publications provided

Responsible Party: Benjamin Zakine, Ipsen
ClinicalTrials.gov Identifier: NCT00578097     History of Changes
Other Study ID Numbers: Y-79-52120-126
Study First Received: December 18, 2007
Last Updated: April 29, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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:
Stress, Psychological
Urinary Bladder, Overactive
Behavioral Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014