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

Phase 2

Withdrawn

• Conditions: Overactive Bladder
• Interventions: Biological: Autologous neobladder construct

• Registration Number: NCT00594139
• Lead Sponsor: Tengion

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.

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Study First Submitted: 2008-01-03
• Study First Submitted QC: 2008-01-03
• Study First Posted: 2008-01-15
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-06
• Last Update Posted: 2018-06-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Autologous neobladder construct	Receipt of autologous neo-bladder construct

Primary Outcome Measures

Name	Time	Method
Mean number of micturitions per day	12 months
Overall safety	12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States