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Procedure
Neo-Bladder Augmentation for Neurogenic Bladder
Phase 2
Waitlist Available
Led By Robert J. Evans, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Must not have
Neurogenic bladder
Any prior bladder augmentation procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6, month 9 and month 12
Awards & highlights
Study Summary
This trial is testing a neo-bladder construct to see if it can improve bladder compliance in patients with fibrotic or contracted bladders. The neo-bladder is a reservoir that is surgically attached to the bladder to help with urine collection.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Potential side effects may include complications from surgery such as infection or bleeding, reactions to materials used in the construct (PGA/PLGA), general anesthesia risks, urinary issues post-operation, and possible need for additional interventions if complications arise.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a condition where my bladder doesn't empty properly due to nerve problems.
Select...
I have had surgery to enlarge my bladder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 6, month 9 and month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6, month 9 and month 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average Number of 24 Hour Voids
Bladder Compliance Average
Secondary outcome measures
American Urological Association Symptom Score (AUASS)
Change in Bladder Capacity
End filling pressure
+4 moreTrial Design
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.
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,252 Previous Clinical Trials
1,010,547 Total Patients Enrolled
Robert J. Evans, MDPrincipal InvestigatorAtrium Health Wake Forest Baptist
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My bladder is small and/or scarred but not due to nerve issues.I am not pregnant, planning to become pregnant, or breastfeeding.I do not have uncontrolled diabetes, unstable heart/lung conditions, or bleeding disorders.I am not able to have children due to surgery, menopause, or age.I have had new kidney or bladder issues in the last year.I have a condition where my bladder doesn't empty properly due to nerve problems.I have not had recent surgery in my urinary system, abdomen, brain, or spine.I did not improve after taking the highest dose of my medication, or I couldn't tolerate it.I can learn and perform self-catheterization.I have had Botulinum Toxin A injections in my bladder in the last year.I have received a blood transfusion in the last 3 months.I use short-term steroids for conditions like asthma.I am immunocompromised or take low-dose immunosuppressive drugs.I cannot have general anesthesia due to health reasons.I haven't had active TB needing treatment in the last 3 years and have no current TB infection.I may have issues with tissue collection for surgery due to internal scarring.I have an ongoing skin infection in my abdomen or a long-term bowel inflammation.My bladder pressure is high, indicating poor bladder function.I do not have HIV, hepatitis B, hepatitis C, active hepatitis A, or any other active infections.I am known to carry MRSA, VRE, or gentamicin-resistant bacteria.I am unable or unwilling to follow the study's procedures.I need surgery to make my bladder larger.My bladder holds less than 150cc.I have had surgery to enlarge my bladder.
Research Study Groups:
This trial has the following groups:- Group 1: Autologous "Neo-Bladder" Construct
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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