Neo-Bladder Augmentation for Neurogenic Bladder
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.
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 data supports the effectiveness of the treatment Neo-Bladder Construct for neurogenic bladder?
Research shows that bladder augmentation, a similar treatment, can significantly increase bladder capacity and reduce pressure in patients with neurogenic bladder, leading to improved continence. This suggests that Neo-Bladder Construct may also be effective in managing neurogenic bladder symptoms.12345
Is bladder augmentation generally safe for humans?
Research shows that bladder augmentation, including techniques like sigmoid bladder augmentation, has been studied for safety in conditions like neurogenic bladder and spina bifida. These studies generally support its long-term safety, although specific risks and complications can vary depending on individual health conditions.12678
How is the Neo-Bladder Construct treatment different from other treatments for neurogenic bladder?
The Neo-Bladder Construct treatment is unique because it involves creating a new bladder using tissue engineering techniques, which may offer a more natural and potentially less invasive alternative to traditional bladder augmentation surgeries that use segments of the intestine. This approach could reduce complications associated with using intestinal tissue, such as mucus production and electrolyte imbalances.2491011
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
Exclusion Criteria
Timeline
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
Treatment Details
Interventions
- Neo-Bladder Construct
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor