Clinical trial NCT00578097: Efficacy and Safety Study of Botulinum Toxin Type-A (Dysport®) in Continent Female Subjects Suffering From Idiopathic Overactive Bladder
Official title: A Phase II, International, Multi-centre, Prospective, Randomised, Parallel-group, Double-blind, Dose-ranging, Placebo-controlled, 12-week, Princeps 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Overactive Bladder
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2007-12-20
Enrollment: 81
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Number of episodes of urgency and frequency of micturition.
timeFrame: Week 12
Secondary outcomes:
measure: The number of episodes of urgency, frequency of micturition, and frequency of nocturia.
timeFrame: All timepoints
measure: Severity of urgency.
timeFrame: All timepoints
measure: Maximum flow rate and post-micturition residual volume (PMRV).
timeFrame: Day 4 and Week 6
measure: Standard International Continence Society (ICS) urodynamic parameters.
timeFrame: Week 12
measure: Quality of Life (QoL).
timeFrame: All timepoints
measure: Safety
timeFrame: All timepoints
measure: Extension study - Duration of effect as determined by the persistence of a positive response.
timeFrame: All timepoints
measure: Extension study - The number of episodes of urgency, frequency of micturition, and frequency of nocturia.
timeFrame: All timepoints
measure: Extension study - Severity of urgency.
timeFrame: All timepoints
measure: Extension study Quality of Life (QoL)
timeFrame: All timepoints
measure: Extension study safety.
timeFrame: All timepoints
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: ULB Hôpital Erasme
city: Huy
country: Belgium
facility: CH Régional Huy - Polyclinique A Rue Trois Ponts
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Liege
country: Belgium
facility: CHU Liege Sart Tilman
city: Olomouc
country: Czechia
facility: Urologická klinika
city: Praha 4
country: Czechia
facility: Urologické oddělení
city: Grenoble Cedex
country: France
facility: Hôpital Michallon - CHU de Grenoble
city: Paris Cedex 16
country: France
facility: Groupe Hospitalier Pitié-Salpétrière
city: Rouen Cedex
country: France
facility: Hôpital Charles Nicolle - CHU de Rouen
city: Saint Genis Laval
country: France
facility: Hôpital Henri Gabrielle - Hôpitaux Civils de Lyon
city: Toulouse
country: France
facility: Hôpital Rangueil - CHU de Toulouse
city: Aachen
country: Germany
facility: Medizinische Einrichtungen der RWTH
city: Bad Kreuznach
country: Germany
facility: Praxis für Urologie
city: Emmendingen
country: Germany
facility: Praxis für Urologie
city: Günzburg
country: Germany
facility: Praxis für Urologie
city: Lahr
country: Germany
facility: Praxis für Urologie
city: München
country: Germany
facility: Beckenboden Zentrum München
city: Neunkirchen
country: Germany
facility: Städtisches Klinikum Neunkirchen gGmbH
city: Pforzheim
country: Germany
facility: Krankenhaus St. Trudpert
city: Firenze
country: Italy
facility: Unità Spinale, Azienda Ospedaliera Careggi
city: Milano
country: Italy
facility: Unità Spinale, Ospedale Niguarda
city: Torino
country: Italy
facility: Struttura Complessa di Neuro-Urologia
city: Maastricht
country: Netherlands
facility: General Urology Academisch Ziekenhuis Maastricht
state: P.Debyelaan 25
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum Amsterdam
city: Nijmegen
country: Netherlands
facility: UMC St. Radboud
city: Rotterdam
country: Netherlands
facility: Erasmus MC, Universitair Medisch Centrum Rotterdam
city: La Laguna
country: Spain
facility: Hospital Clínico Universitario Canarias
city: Madrid
country: Spain
facility: Hospital San Rafael
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
city: Bristol
country: United Kingdom
facility: Southmead Hospital
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: London
country: United Kingdom
facility: St George's Hospital
city: Oxford
country: United Kingdom
facility: Churchill Hospital
city: Reading
country: United Kingdom
facility: Royal Berkshire Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: