Neo-Bladder Augmentation for Neurogenic Bladder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called the "neo-bladder" construct for individuals with a fibrotic or contracted bladder, which holds little urine and can cause high pressure. The goal is to determine if this new bladder pouch can safely improve urine collection over time. Ideal candidates for this trial are those who have tried medications but still experience bladder issues and require surgery to prevent kidney problems. Participants should be capable of performing tasks like catheterization and bladder cycling. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have failed to respond to the maximum approved dose of medical therapy or have a contraindication to such agents, which might imply some changes to your current medication regimen.
What prior data suggests that the neo-bladder construct is safe for treating neurogenic bladder?
Research has shown that treatments similar to the neo-bladder construct, such as surgeries to enlarge the bladder, have been well-received by patients. These procedures can increase bladder size and reduce pressure, helping to protect the kidneys over time. In one study, more than half of the patients reported moderate to extreme satisfaction with their treatment results.
However, some risks require consideration. The most common issue was the development of a vesicourethral fistula, a small, unusual connection that can form between the bladder and the urethra, occurring in about 15% of patients. Despite this, the treatment generally maintained good kidney health. This suggests that the neo-bladder construct could be a safe option, but discussing these potential risks with a healthcare provider is important.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatment options for neurogenic bladder, which often include medications or traditional bladder augmentation surgeries, the Neo-Bladder Construct is unique because it's made from the patient’s own tissue. This personalized approach aims to create a new bladder that is more compatible with the body, potentially reducing the risk of rejection and complications. Researchers are excited about this treatment because it could provide a more natural and long-lasting solution for patients with fibrotic contracted bladders, helping to prevent severe complications like kidney failure by effectively managing high bladder pressures.
What evidence suggests that the Neo-Bladder Construct might be an effective treatment for neurogenic bladder?
Research has shown that bladder augmentation, a treatment similar to the neo-bladder construct studied in this trial, can significantly increase bladder size and reduce pressure in patients with neurogenic bladder. In some cases, the bladder's ability to stretch and hold urine improved by up to 179% after surgery. Patients who previously received an autologous neo-bladder construct reported moderate to excellent satisfaction with their results. These findings suggest that the neo-bladder construct could effectively increase bladder capacity and lower pressure, which is important for preventing kidney problems.13467
Who Is on the Research Team?
Robert J Evans, MD
Principal Investigator
Atrium Health Wake Forest Baptist
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Cell Expansion and Neo-Bladder Construction
Participants undergo a bladder biopsy, and cells are expanded ex vivo to create the neo-bladder construct
Surgical Implantation
The neo-bladder construct is surgically implanted onto the native bladder during augmentation cystoplasty
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Neo-Bladder Construct
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor