Neo-Bladder Augmentation for Neurogenic Bladder

Recruiting in Palo Alto (17 mi)

Overseen byRobert J Evans, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Wake Forest University Health Sciences

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to find out if autologous "neo-bladder" construct for the treatment of fibrotic and/or contracted bladder can improve bladder compliance and be safe long term. The neo-bladder is like a reservoir or pouch that will be surgically attached to the bladder to assist with urine collection.

Research Team

Robert J Evans, MD

Principal Investigator

Atrium Health Wake Forest Baptist

Eligibility Criteria

This trial is for individuals with a neurogenic bladder who have not responded to standard medical treatments and are able to perform self-catheterization. They must have a small bladder capacity (<150cc) or poor bladder compliance, and be willing to consent in English. Excluded are those with recent surgeries, infections like HIV/HBV/HCV/TB, allergies to certain materials, drug abuse history, pregnant or breastfeeding women, and those on certain medications.

Inclusion Criteria

My bladder is small and/or scarred but not due to nerve issues.

Willing and able to give signed informed consent in English

I have had new kidney or bladder issues in the last year.

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Exclusion Criteria

Prior participation in the study

Current incarceration for any reason

I am not pregnant, planning to become pregnant, or breastfeeding.

See 26 more

Treatment Details

Interventions

Neo-Bladder Construct (Procedure)

Trial OverviewThe study tests an autologous 'neo-bladder' construct surgically attached to the patient's bladder as a new treatment method for improving urine collection in patients with fibrotic or contracted bladders. The safety and effectiveness of this neo-bladder will be evaluated over time.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Autologous "Neo-Bladder" ConstructExperimental Treatment1 Intervention

All subjects enrolled will have non-neurogenic, fibrotic contracted bladder that is refractory to medical treatment and require augmentation cystoplasty for preventing long-term sequelae (i.e., kidney failure) that result from persistently high intravesical pressure.