Augmentation Cystoplasty Using an Autologous Neo-Bladder Construct

August 24, 2026 updated by: Wake Forest University Health Sciences

A Phase 2 Study of Augmentation Cystoplasty Using an Autologous Neo-Bladder Construct In Subjects With Fibrotic Contracted Bladder

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a prospective, open-label, single-group clinical study. All subjects 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. Subjects will undergo an open full thickness bladder biopsy from which autologous urinary bladder smooth muscle and urothelial cells will be procured and expanded ex vivo. After approximately 5 - 7 weeks, expanded cells will be seeded on a biodegradable scaffold to produce the neo-bladder construct that will be surgically implanted onto an opened native bladder during an augmentation cystoplasty. Subjects will be followed for 36 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Atrium Health Wake Forest Baptist
        • Contact:
        • Principal Investigator:
          • Robert J Evans, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects with small contracted and/or fibrotic non-neurogenic bladder.
  • Small bladder <150cc capacity
  • Willing and able to give signed informed consent in English.
  • Ability of subject to be successfully trained in clean intermittent catheterization and bladder cycling
  • Failure to respond to maximum approve dose of medical therapy (e.g. anticholinergics) or failure to tolerate /contraindication to such agents

  • Medical need for bladder augmentation, as defined by the presence of:

    1. Decreased and inadequate bladder compliance with a bladder pressure ≥40 cmH20. OR
    2. New-onset of upper urinary tract changes (hydronephrosis, vesicoureteral reflux) in the last 12 months

Exclusion:

  • Neurogenic bladder
  • Recent (< 12 months) urological or intraperitoneal surgery or device implantation; recent (<6 month neurologic surgery-brain or spine)
  • Any prior bladder augmentation procedure
  • Known or suspected limitation to obtaining omentum for implantation procedure (e.g., extensive intraperitoneal adhesions)
  • Any contraindication to general anesthesia
  • Any contraindication or known anaphylactic or severe systemic reaction to either human blood products or materials of bovine origin
  • Human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV), active hepatitis A (HAV) or other known active infection
  • Subjects with active tuberculosis (TB) requiring treatment in the past 3 years. Subjects with a current positive (≥5 mm induration for high-risk subjects; otherwise ≥10 mm of induration) purified protein derivative (PPD) test are excluded unless they have completed a full course of treatment for latent TB and have a negative chest x-ray film at enrollment.
  • Subjects known to be colonized with either methicillin-resistant staphylococcus aureus (MRSA) or vancomycin-resistant Enterococcus (VRE), or gentamicin-resistant organisms.
  • Receipt of blood or blood products for transfusion during the 3 months prior to biopsy
  • Immunocompromised subjects or subjects receiving immunosuppressive agents (inhaled corticosteroids and chronic low-dose corticosteroids [≤0.25 mg/kg prednisone or equivalent per day] are permitted).
  • Brief pulsed corticosteroids for intermittent symptoms (e.g., asthma) are permitted.
  • Known history of hypersensitivity to aminoglycosides or fluoroquinolones.
  • History of true allergy to iodine or iodinated x-ray contrast agents
  • Use of any investigational product within 3 months
  • Prior participation in the study
  • Any history of alcohol and/or any drug abuse
  • Current incarceration for any reason
  • Unwillingness, inability, or unlikely compliance with study related procedures
  • Any circumstance in which the investigator deems participation in the study is not in the subject's best interest
  • Subjects with an Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) value >3 times the upper limit of normal
  • Subjects with an albumin value <3.0 g/dL
  • Subjects with a history of an anaphylactic or a severe systemic reaction to the biodegradable polymers glycolic acid (PGA) and lactic-co-glycolic acid (PLGA)
  • Subjects with acute or chronic abdominal skin infections and/or acute or chronic inflammatory bowel disease
  • Subjects with uncontrolled diabetes, unstable cardiac and/or pulmonary disorders, or bleeding disorders
  • Subjects who have received Botulinum Toxin A injections into the bladder within the previous 12 months.
  • Female subjects who are pregnant, planning to get pregnant or lactating/breast-feeding.

  • Female subjects of child-bearing potential unwilling to practice an effective method of birth control as determined by the investigator (e.g., oral contraceptives, double barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or partner with vasectomy) for duration of the study.

    • If a patient has had a hysterectomy, a bilateral oophorectomy, documented ovarian failure or is older than age 51.5 years and has not had a menstrual period in more than 12 months, they will be considered to be non-childbearing. This will be ascertained from patient interview/self-report, medical records (if necessary) and the investigator's judgment. "Spontaneous menopause," occurs in the United States at a mean age of 51.5 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Autologous "Neo-Bladder" Construct
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.
Biological: "Neo-Bladder" Construct
Subjects will undergo an open full thickness bladder biopsy from which autologous urinary bladder smooth muscle and urothelial cells will be procured and expanded ex vivo. After approximately 5 - 7 weeks, expanded cells will be seeded on a biodegradable scaffold to produce the neo-bladder construct that will be surgically implanted onto an opened native bladder during an augmentation cystoplasty.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Bladder Compliance Average
Time Frame: Month 12
Average bladder capacity as found on Urodynamics results
Month 12
Average Number of 24 Hour Voids
Time Frame: Month 6
Per voiding diary
Month 6
Average Number of 24 Hour Voids
Time Frame: Month 9
Per voiding diary
Month 9
Average Number of 24 Hour Voids
Time Frame: Month 12
Per voiding diary
Month 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Bladder Capacity
Time Frame: From Baseline through Month 12
Shown through urodynamics study
From Baseline through Month 12
End filling pressure
Time Frame: Baseline, Month 6, Month 9 and Month 12
At age-related nomogram-derived bladder capacity
Baseline, Month 6, Month 9 and Month 12
Urogenital Distress Inventory-6 Question (UDI-6)
Time Frame: Month 6, Month 9 and Month 12
Evaluation of urogenital function from self-reported questionnaire. Score ranges from 0-18 with higher score denoting worsening in urogenital function.
Month 6, Month 9 and Month 12
Urogenital Distress Inventory-7 Question (UDI-7)
Time Frame: Month 6, Month 9 and Month 12
Evaluation of urogenital function from self-reported questionnaire. Score ranges from 0-21 with higher score denoting worsening in urogenital function.
Month 6, Month 9 and Month 12
Genitourinary Pain Index (GUPI)
Time Frame: Month 6, Month 9 and Month 12
Evaluation of pain from self-reported questionnaire. Score ranges from 0-45 with a higher score denoting worse symptoms.
Month 6, Month 9 and Month 12
Quality of Life (QOL) Questionnaire
Time Frame: Month 6, Month 9 and Month 12
Self-reported quality of life evaluation. Score ranges from 0-6 with highest score denoting the worst feelings about quality of life.
Month 6, Month 9 and Month 12
American Urological Association Symptom Score (AUASS)
Time Frame: Month 6, Month 9 and Month 12
Self-reported urological symptom assesment. Score ranges from 1-35 with score of 1-7 denoting mild symptoms, 8-19 denoting moderate symptoms and 20-35 denoting severe symptoms.
Month 6, Month 9 and Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert J. Evans, MD, Atrium Health Wake Forest Baptist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00076977

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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