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

Tengion

Status and phase

Withdrawn

Phase 2

Conditions

Overactive Bladder

Treatments

Biological: Autologous neobladder construct

Study type

Interventional

Funder types

Industry

Identifiers

NCT00594139

TNG-CL006

Details and patient eligibility

About

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.

Full description

Subjects with non-neurogenic over-active bladder and urge predominant incontinence who are intolerant to medical therapy or have persistence of symptoms despite medical therapy and require augmentation cystoplasty 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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