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

Tengion

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Overactive Bladder

Interventions

Autologous neobladder constructBIOLOGICAL

provision of an autologous neo-bladder construct

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Vanderbilt University

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Mean number of micturitions per day

Time frame: 12 months

Overall safety

Time frame: 12 months

Secondary Outcomes

Mean voided volumes, mean number of incontinent episodes, mean number of micturitions, cystometric capacity, detrusor pressure, end filling pressure and complaince

Time frame: periodically within first 12 months as well as during long term follow up out to 5 years

Data from ClinicalTrials.gov

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