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

NCT ID: NCT00594139

Last Updated: 2018-06-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2008-01-31

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.

Conditions

Overactive Bladder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Receipt of autologous neo-bladder construct

Group Type: EXPERIMENTAL

Autologous neobladder construct

Intervention Type: BIOLOGICAL

provision of an autologous neo-bladder construct

Interventions

Autologous neobladder construct

provision of an autologous neo-bladder construct

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tengion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Tillinger, MD

Role: STUDY_DIRECTOR

Tengion, Inc

Locations

Vanderbilt University

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

TNG-CL006

Identifier Type: -

Identifier Source: org_study_id