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

Overactive Bladder Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00594139
• Other study ID #: TNG-CL006
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 2008
• Est. completion date: January 2008

Study information

• Verified date: June 2018
• Source: Tengion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Biological:
• Autologous neobladder construct
provision of an autologous neo-bladder construct

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Tengion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean number of micturitions per day		12 months
Primary	Overall safety		12 months
Secondary	Mean voided volumes, mean number of incontinent episodes, mean number of micturitions, cystometric capacity, detrusor pressure, end filling pressure and complaince		periodically within first 12 months as well as during long term follow up out to 5 years