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

• Status: Terminated
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

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.