Study of Autologous Neo-Bladder Construct in Subjects With Non-Neurogenic Overactive Bladder and Urge Predominant Incontinence - Tabular View

Tracking Information

First Received Date ^ICMJE

January 3, 2008

Last Updated Date

February 26, 2009

Start Date ^ICMJE

January 2008

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Mean number of micturitions per day [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Overall safety [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00594139 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Study of Autologous Neo-Bladder Construct in Subjects With Non-Neurogenic Overactive Bladder and Urge Predominant Incontinence

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Overactive Bladder

Intervention ^ICMJE

Other: Autologous neobladder construct

Study Arms / Comparison Groups

Experimental: Receipt of autologous neo-bladder construct

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00594139

Responsible Party

Elyse Seltzer, MD, Tengion, Inc

Study ID Numbers ^ICMJE

TNG-CL006

Study Sponsor ^ICMJE

Tengion

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Elyse G Seltzer, MD

Tengion, Inc

Information Provided By

Tengion

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP