Augmentation Cystoplasty Using an Autologous Neo-Bladder Construct
ConditionContracted Bladder
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorWake Forest University Health Sciences
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
"Neo-Bladder" Construct
Biological/VaccineSubjects 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Autologous "Neo-Bladder" ConstructExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Bladder Compliance Average
Average bladder capacity as found on Urodynamics results
Time frame
Month 122
Average Number of 24 Hour Voids
Per voiding diary
Time frame
Month 63
Average Number of 24 Hour Voids
Per voiding diary
Time frame
Month 94
Average Number of 24 Hour Voids
Per voiding diary
Time frame
Month 12Secondary outcomes
1
Change in Bladder Capacity
Shown through urodynamics study
Time frame
From Baseline through Month 122
End filling pressure
At age-related nomogram-derived bladder capacity
Time frame
Baseline, Month 6, Month 9 and Month 123
Urogenital Distress Inventory-6 Question (UDI-6)
Evaluation of urogenital function from self-reported questionnaire. Score ranges from 0-18 with higher score denoting worsening in urogenital function.
Time frame
Month 6, Month 9 and Month 124
Urogenital Distress Inventory-7 Question (UDI-7)
Evaluation of urogenital function from self-reported questionnaire. Score ranges from 0-21 with higher score denoting worsening in urogenital function.
Time frame
Month 6, Month 9 and Month 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: