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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Open Label Multi-center Study of Augmentation Cystoplasty Using an Autologous Neo-Bladder Construct in Subjects With Non-Neurogenic Overactive Bladder and Urge Predominant Incontinence

Conditions
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Overactive Bladder

Intervention / Treatment
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* Biological: Autologous neobladder construct


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Receipt of autologous neo-bladder construct | Biological: Autologous neobladder construct<br>* provision of an autologous neo-bladder construct<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean number of micturitions per day |  | 12 months | 
| Overall safety |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean voided volumes, mean number of incontinent episodes, mean number of micturitions, cystometric capacity, detrusor pressure, end filling pressure and complaince |  | periodically within first 12 months as well as during long term follow up out to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-neurogenic over active bladder, urge predominant incontinence