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

Phase 2

Terminated

• Conditions: Overactive Bladder
• Interventions: Biological: Botulinum toxin type A; Drug: Placebo

• Registration Number: NCT00578097
• Lead Sponsor: Ipsen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-12-18
• Study First Submitted QC: 2007-12-18
• Study First Posted: 2007-12-20
• Study Start: 2008-02
• Primary Completion: 2009-06
• Study Completion: 2009-12
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-21
• Last Update Posted: 2019-11-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 81

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C - 500 units	Botulinum toxin type A	-
D	Placebo	-
B - 250 units	Botulinum toxin type A	-
A - 125 units	Botulinum toxin type A	-

Primary Outcome Measures

Name	Time	Method
Number of episodes of urgency and frequency of micturition.	Week 12

Secondary Outcome Measures

Name	Time	Method
Extension study - Duration of effect as determined by the persistence of a positive response.	All timepoints
Standard International Continence Society (ICS) urodynamic parameters.	Week 12
The number of episodes of urgency, frequency of micturition, and frequency of nocturia.	All timepoints
Extension study - Severity of urgency.	All timepoints
Quality of Life (QoL).	All timepoints
Extension study Quality of Life (QoL)	All timepoints
Extension study safety.	All timepoints
Severity of urgency.	All timepoints
Maximum flow rate and post-micturition residual volume (PMRV).	Day 4 and Week 6
Extension study - The number of episodes of urgency, frequency of micturition, and frequency of nocturia.	All timepoints
Safety	All timepoints

Trial Locations

Locations (31)

UZ Gasthuisberg; 🇧🇪 Leuven, Belgium

Urologická klinika; 🇨🇿 Olomouc, Czechia

Hôpital Michallon - CHU de Grenoble; 🇫🇷 Grenoble Cedex, France

Groupe Hospitalier Pitié-Salpétrière; 🇫🇷 Paris Cedex 16, France

Hôpital Charles Nicolle - CHU de Rouen; 🇫🇷 Rouen Cedex, 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; 🇩🇪 Lahr, Germany

Städtisches Klinikum Neunkirchen gGmbH; 🇩🇪 Neunkirchen, Germany

Krankenhaus St. Trudpert; 🇩🇪 Pforzheim, Germany

Unità Spinale, Azienda Ospedaliera Careggi; 🇮🇹 Firenze, Italy

VU Medisch Centrum Amsterdam; 🇳🇱 Amsterdam, Netherlands

UMC St. Radboud; 🇳🇱 Nijmegen, Netherlands

Erasmus MC, Universitair Medisch Centrum Rotterdam; 🇳🇱 Rotterdam, Netherlands

Hospital Clínico Universitario Canarias; 🇪🇸 La Laguna, Spain

Hospital San Rafael; 🇪🇸 Madrid, Spain

St George's Hospital; 🇬🇧 London, United Kingdom

Southmead Hospital; 🇬🇧 Bristol, United Kingdom

Royal Berkshire Hospital; 🇬🇧 Reading, United Kingdom

ULB Hôpital Erasme; 🇧🇪 Brussels, Belgium

CH Régional Huy - Polyclinique A Rue Trois Ponts; 🇧🇪 Huy, Belgium

CHU Liege Sart Tilman; 🇧🇪 Liege, Belgium

General Urology Academisch Ziekenhuis Maastricht; 🇳🇱 Maastricht, P.Debyelaan 25, Netherlands

Unità Spinale, Ospedale Niguarda; 🇮🇹 Milano, Italy

Struttura Complessa di Neuro-Urologia; 🇮🇹 Torino, Italy

Western General Hospital; 🇬🇧 Edinburgh, United Kingdom

Churchill Hospital; 🇬🇧 Oxford, United Kingdom

Beckenboden Zentrum München; 🇩🇪 München, Germany

Hospital Universitario La Fe; 🇪🇸 Valencia, Spain

Urologické oddělení; 🇨🇿 Praha 4, Czechia