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

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ClinicalTrials.gov Identifier: NCT00594139
Recruitment Status : Withdrawn (Reprioritization of study programs)
First Posted : January 15, 2008
Last Update Posted : November 3, 2015
Sponsor:
Information provided by (Responsible Party):
Tengion

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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Biological: Autologous neobladder construct Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Receipt of autologous neo-bladder construct
Biological: Autologous neobladder construct
provision of an autologous neo-bladder construct



Primary Outcome Measures :
  1. Mean number of micturitions per day [ Time Frame: 12 months ]
  2. Overall safety [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00594139


Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Tengion
Investigators
Study Director: Michael Tillinger, MD Tengion, Inc

Responsible Party: Tengion
ClinicalTrials.gov Identifier: NCT00594139     History of Changes
Other Study ID Numbers: TNG-CL006
First Posted: January 15, 2008    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: November 2015

Keywords provided by Tengion:
non-neurogenic over active bladder
urge predominant incontinence

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms