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

Sponsor:	Tengion
Information provided by:	Tengion
ClinicalTrials.gov Identifier:	NCT00594139

Purpose

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.

Condition	Intervention	Phase
Overactive Bladder	Other: Autologous neobladder construct	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Urinary Incontinence Urine and Urination

Drug Information available for: Phenylephrine Phenylephrine hydrochloride Oxymetazoline Oxymetazoline hydrochloride

U.S. FDA Resources

Further study details as provided by Tengion:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	0
Study Start Date:	January 2008

Arms	Assigned Interventions
Experimental: 1 Receipt of autologous neo-bladder construct	Other: Autologous neobladder construct provision of an autologous neo-bladder construct

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594139

Locations

United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Tengion

Investigators

Study Director:

Michael Tillinger, MD

Tengion, Inc

More Information

No publications provided

Responsible Party:	Michael Tillinger, MD, Executive Director Clinical Development and Medical Affairs, Tengion, Inc
ClinicalTrials.gov Identifier:	NCT00594139 History of Changes
Other Study ID Numbers:	TNG-CL006
Study First Received:	January 3, 2008
Last Updated:	December 8, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Tengion:

non-neurogenic over active bladder
urge predominant incontinence

Additional relevant MeSH terms:

Urinary Incontinence
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases

Urological Manifestations
Signs and Symptoms
Urinary Bladder Diseases

ClinicalTrials.gov processed this record on February 12, 2012