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

This study has been withdrawn prior to enrollment.
(Reprioritization of study programs)
Sponsor:
Information provided by:
Tengion
ClinicalTrials.gov Identifier:
NCT00594139
First received: January 3, 2008
Last updated: December 8, 2009
Last verified: December 2009
History of Changes
  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 2

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:

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 Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013