TerminatedPhase 2

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

Stopped: The study was terminated early due to poor recruitment.

Belgium, Czechia, France81 participantsStarted 2008-02

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of episodes of urgency and frequency of micturition.

Timeframe: Week 12

Trial details

NCT IDNCT00578097

SponsorIpsen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-06

View on ClinicalTrials.gov More Overactive Bladder trials