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.

Ipsen31 sites in 8 countries81 target enrollmentFebruary 2008

ConditionsOveractive Bladder

InterventionsBotulinum toxin type A Placebo

DrugsPlacebo

Overview

Phase: Phase 2
Intervention: Botulinum toxin type A
Conditions: Overactive Bladder
Sponsor: Ipsen
Enrollment: 81
Locations: 31
Primary Endpoint: Number of episodes of urgency and frequency of micturition.
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2008

End Date

December 2009

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Ipsen

Responsible Party

Sponsor

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.

Arms & Interventions

A - 125 units

Intervention: Botulinum toxin type A

B - 250 units

Intervention: Botulinum toxin type A

C - 500 units

Intervention: Botulinum toxin type A

D

Intervention: Placebo

Outcomes

Primary Outcomes

Number of episodes of urgency and frequency of micturition.

Time Frame: Week 12

Secondary Outcomes

Safety(All timepoints)
Extension study - The number of episodes of urgency, frequency of micturition, and frequency of nocturia.(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)
Quality of Life (QoL).(All timepoints)
Extension study Quality of Life (QoL)(All timepoints)
Extension study safety.(All timepoints)
Maximum flow rate and post-micturition residual volume (PMRV).(Day 4 and Week 6)
Severity of urgency.(All timepoints)