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
Safety	All timepoints
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
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
Quality of Life (QoL).	All timepoints

Trial Locations

Locations (31)

ULB Hôpital Erasme; 🇧🇪 Brussels, Belgium

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

UZ Gasthuisberg; 🇧🇪 Leuven, Belgium

CHU Liege Sart Tilman; 🇧🇪 Liege, Belgium

Urologická klinika; 🇨🇿 Olomouc, Czechia

Urologické oddělení; 🇨🇿 Praha 4, 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

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