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

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00594139

Enrollment

Registered

2008-01-15

Start date

2008-01-31

Completion date

2008-01-31

Last updated

2018-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder

Keywords

non-neurogenic over active bladder, urge predominant incontinence

Brief 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.

Detailed 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.

Interventions

BIOLOGICALAutologous neobladder construct

provision of an autologous neo-bladder construct

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Mean number of micturitions per day	12 months
Overall safety	12 months

Secondary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026