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

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.

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00578097

Enrollment

Registered

2007-12-20

Start date

2008-02-29

Completion date

2009-12-31

Last updated

2019-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder

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.

Interventions

BIOLOGICALBotulinum toxin type A

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.

DRUGPlacebo

Single injection cycle, intradetrusor injection at baseline (visit 2).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
Number of episodes of urgency and frequency of micturition.	Week 12

Secondary

Measure	Time frame
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
The number of episodes of urgency, frequency of micturition, and frequency of nocturia.	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
Extension study - Duration of effect as determined by the persistence of a positive response.	All timepoints

Countries

Belgium, Czechia, France, Germany, Italy, Netherlands, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026