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

Ipsen

Status and phase: Terminated; Phase 2

Conditions: Overactive Bladder

Treatments: Drug: Placebo; Biological: Botulinum toxin type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00578097

Y-79-52120-126

2007-002999-34 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 81 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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81 participants in 4 patient groups, including a placebo group

A - 125 units

Experimental group

Treatment:

Biological: Botulinum toxin type A

B - 250 units

Experimental group

Treatment:

Biological: Botulinum toxin type A

C - 500 units

Experimental group

Treatment:

Biological: Botulinum toxin type A

D

Placebo Comparator group

Treatment:

Drug: Placebo