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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Overactive Bladder

Intervention / Treatment
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* Biological: Botulinum toxin type A
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A - 125 units<br> | Biological: Botulinum toxin type A<br>* Single injection cycle, intradetrusor injection at baseline visit 2 of either 125 units (arm A), 250 units (arm B) or 500 units (arm C) in total.<br>* Other names: AbobotulinumtoxinA (Dysport®);|
| Experimental: B - 250 units<br> | Biological: Botulinum toxin type A<br>* Single injection cycle, intradetrusor injection at baseline visit 2 of either 125 units (arm A), 250 units (arm B) or 500 units (arm C) in total.<br>* Other names: AbobotulinumtoxinA (Dysport®);|
| Experimental: C - 500 units<br> | Biological: Botulinum toxin type A<br>* Single injection cycle, intradetrusor injection at baseline visit 2 of either 125 units (arm A), 250 units (arm B) or 500 units (arm C) in total.<br>* Other names: AbobotulinumtoxinA (Dysport®);|
| Placebo Comparator: D<br> | Drug: Placebo<br>* Single injection cycle, intradetrusor injection at baseline (visit 2).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of episodes of urgency and frequency of micturition. |  | Week 12 | 

Secondary Outcome Measures

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