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| 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: | 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 |
| Enrollment: | 0 |
| Study Start Date: | January 2008 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Tengion, Inc ( Elyse Seltzer, MD ) |
| Study ID Numbers: | TNG-CL006 |
| Study First Received: | January 3, 2008 |
| Last Updated: | February 26, 2009 |
| ClinicalTrials.gov Identifier: | NCT00594139 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
non-neurogenic over active bladder urge predominant incontinence |
|
Signs and Symptoms Urological Manifestations Urinary Bladder, Overactive Urologic Diseases |
Urination Disorders Urinary Bladder Diseases Urinary Incontinence |