Neurogenic Bladder
Conditions
Brief summary
Subjects with neurogenic bladder secondary to spinal cord injury that is refractory to medical treatment and requires augmentation cystoplasty will be enrolled. The hypothesis is that augmentation cystoplasty using an autologous neo-bladder construct will reduce maximum detrusor pressure.
Interventions
augmentation cystoplasty with autologous neo-bladder construct
Sponsors
Tengion
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Note: Tengion no longer exists following Chapter 7 bankruptcy in 2014. No further information is available. No data are available to be reviewed or re-analyzed.
Intervention model description
Note: Tengion no longer exists following Chapter 7 bankruptcy in 2014. No further information is available. No data are available to be reviewed or re-analyzed.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* subjects with neurogenic bladders secondary to spinal cord injury
Exclusion criteria
* prior augmentation procedures or urinary diversion * recent urologic or intraperitoneal surgery or device implantation * recent history of spinal cord injury of less than a year * recent neurologic surgery * requirement for concomitant urological surgical procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Maximum Detrusor Pressure From Baseline to 12 Months | baseline and 12 months | Detrusor pressure is measured using urodynamic testing, which involves inserting a catheter through the urethra and into the bladder and measuring the pressure in the bladder as it is filled with fluid. The primary outcome measure for this study was the change in the maximum pressure observed during bladder filling from baseline to 12 months. The goal of the therapy was to decrease pressure. |
| Overall Safety Profile - Number of Participants Experiencing an Adverse Event | through month 12 | Clinical evaluation of adverse events experienced by patients enrolled in the trial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urodynamic Measurements and Long Term Safety | month 12 through month 60 | Safety results are summarized in the Adverse Events section of this listing. |
Countries
United States
Participant flow
Recruitment details
7 patients were recruited between September 2007 and October 2008. Patients were recruited from 4 academic centers across the US. 1 patient withdrew consent prior to bladder biopsy and is included in the safety analysis but not in the efficacy analysis. Due to recruitment challenges, only 6 patients were implanted.
Pre-assignment details
This was an open label, single arm study.
Participants by arm
| Arm | Count |
|---|---|
| Enterocystoplasty With the Neo-bladder Augment Patients were enrolled who required enterocystoplasty (bladder augmentation). Patients in this study were augmented with with the Tengion neo-bladder augment. During this procedure the neo-bladder augment was surgically attached to the patient's existing bladder to enlarge its size. | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Primay Study Period | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Enterocystoplasty With the Neo-bladder Augment |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Age, Continuous | 28.7 years STANDARD_DEVIATION 11.41 |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 7 |
| serious Total, serious adverse events | 4 / 7 |
Outcome results
Primary
Change in Maximum Detrusor Pressure From Baseline to 12 Months
Detrusor pressure is measured using urodynamic testing, which involves inserting a catheter through the urethra and into the bladder and measuring the pressure in the bladder as it is filled with fluid. The primary outcome measure for this study was the change in the maximum pressure observed during bladder filling from baseline to 12 months. The goal of the therapy was to decrease pressure.
Time frame: baseline and 12 months
Population: All patients with urodynamics measurement performed at baseline and month 12 were included in the analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Implanted | Change in Maximum Detrusor Pressure From Baseline to 12 Months | -17.0 centimeters of water (cm H2O) |
Primary
Overall Safety Profile - Number of Participants Experiencing an Adverse Event
Clinical evaluation of adverse events experienced by patients enrolled in the trial.
Time frame: through month 12
Population: This analysis was performed on the safety population. Patients undergoing screening and meeting inclusion/exclusion criteria were included in the safety population. Tengion no longer exists following Chapter 7 bankruptcy in 2014. No further data analysis will be made.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Implanted | Overall Safety Profile - Number of Participants Experiencing an Adverse Event | 7 participants |
Secondary
Urodynamic Measurements and Long Term Safety
Safety results are summarized in the Adverse Events section of this listing.
Time frame: month 12 through month 60
Population: Tengion no longer exists following Chapter 7 bankruptcy in 2014. No data were analyzed.