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

Primary Purpose

Overactive Bladder

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Autologous neobladder construct

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring non-neurogenic over active bladder, urge predominant incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Vanderbilt University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Receipt of autologous neo-bladder construct

Outcomes

Primary Outcome Measures

Mean number of micturitions per day

Overall safety

Secondary Outcome Measures

Mean voided volumes, mean number of incontinent episodes, mean number of micturitions, cystometric capacity, detrusor pressure, end filling pressure and complaince

Full Information

NCT ID

NCT00594139

First Posted

January 3, 2008

Last Updated

June 6, 2018

Sponsor

Tengion

1. Study Identification

Unique Protocol Identification Number

NCT00594139

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Withdrawn

Why Stopped

Reprioritization of study programs

Study Start Date

January 2008 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tengion

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overactive Bladder

Keywords

non-neurogenic over active bladder, urge predominant incontinence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Receipt of autologous neo-bladder construct

Intervention Type

Biological

Intervention Name(s)

Autologous neobladder construct

Intervention Description

provision of an autologous neo-bladder construct

Primary Outcome Measure Information:

Title

Mean number of micturitions per day

Time Frame

12 months

Title

Overall safety

Time Frame

12 months

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Tillinger, MD

Organizational Affiliation

Tengion, Inc

Official's Role

Study Director

Facility Information:

Facility Name

Vanderbilt University

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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