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

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

MedlinePlus related topics:

Urinary Incontinence

Drug Information available for:

Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

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 ]

Estimated Enrollment:	10
Study Start Date:	January 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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:	Elyse G Seltzer, MD	Tengion, Inc

More Information

Responsible Party:	Tengion, Inc ( Elyse Seltzer, MD )
Study ID Numbers:	TNG-CL006
First Received:	January 3, 2008
Last Updated:	October 24, 2008
ClinicalTrials.gov Identifier:	NCT00594139
Health Authority:	United States: Food and Drug Administration

Keywords provided by Tengion:

non-neurogenic over active bladder

urge predominant incontinence

Study placed in the following topic categories:

Naphazoline

Oxymetazoline

Signs and Symptoms

Urinary Bladder, Overactive

Urologic Diseases

Guaifenesin

Phenylephrine

Urination Disorders

Urinary Bladder Diseases

Urinary Incontinence

Phenylpropanolamine

Additional relevant MeSH terms:

Urological Manifestations

ClinicalTrials.gov processed this record on November 19, 2008

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