WithdrawnPhase 2

Autologous Neo-Bladder Construct in Non-Neurogenic Overactive Bladder and Urge Predominant Incontinence

Stopped: Reprioritization of study programs

United States0Started 2008-01

Plain-language summary

Subjects with non-neurogenic over-active bladder will be enrolled. The hypothesis is that augmentation cystoplasty using an autologous neo-bladder construct will increase functional capacity and thereby reduce the number of micturition episodes per day in subjects with non-neurogenic over active bladder and urge predominant incontinence.

Who can participate

Age range18 Years

SexALL

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: * History of non-neurogenic overactive bladder for at least 12 months prior to study entry * Intolerance to medical therapy or persistence of symptoms despite medical therapy Exclusion Criteria: * Subjects with stress incontinence or mixed incontinence where the predominant component is stress incontinence * Use of Botulinum Toxin A injections into the bladder within the previous 6 months * Presence of a neuromodulator * Using catheterization as a way to control incontinence * History of bladder cancer

What they're measuring

Mean number of micturitions per day

Timeframe: 12 months

Overall safety

Timeframe: 12 months

Trial details

NCT IDNCT00594139

SponsorTengion

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-01

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