NCT00594139

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 15, 2008

Completed
Last Updated

June 8, 2018

Status Verified

June 1, 2018

Enrollment Period

Same day

First QC Date

January 3, 2008

Last Update Submit

June 6, 2018

Conditions

Overactive Bladder

Keywords

non-neurogenic over active bladderurge predominant incontinence

Outcome Measures

Primary Outcomes (2)

  • Mean number of micturitions per day

    12 months

  • Overall safety

    12 months

Secondary Outcomes (1)

  • 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

Study Arms (1)

1

EXPERIMENTAL

Receipt of autologous neo-bladder construct

Biological: Autologous neobladder construct

Interventions

Autologous neobladder constructBIOLOGICAL

provision of an autologous neo-bladder construct

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Tillinger, MD

    Tengion, Inc

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2008

First Posted

January 15, 2008

Study Start

January 1, 2008

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

June 8, 2018

Record last verified: 2018-06

Locations

US(1)