Stress Urinary Incontinence
Conditions
Brief summary
The Autologous Cell Therapy for Female SUI study is a clinical trial to determine the safety and potential effectiveness of a single dose of 200 million Cook MyoSite Autologous Muscle Derived Cells for treatment of Stress Urinary Incontinence.
Interventions
BIOLOGICALAutologous Muscle Derived Cells
Urethral injection of autologous muscle-derived cells
Sponsors
Cook MyoSite
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* SUI with normal detrusor activity confirmed with urodynamics * Bladder capacity \>200 ml * Incontinence has not shown any improvement for at least -6 months * Failed prior treatments (e.g., behavior modification, bladder exercises, biofeedback, electrical stimulation, bulking injections, urethral suspensions and/or drug therapy)
Exclusion criteria
* Known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant pelvic floor abnormalities with high pressure instability * Neuromuscular disorder (e.g., muscular dystrophy, multiple sclerosis) * Uncontrolled diabetes * Pregnant, lactating, or plans to become pregnant during course of the study * Morbid obesity (defined as 100 pounds over their ideal body weight, or BMI ≥40) and not expected to benefit from treatment * Current or acute conditions involving cystitis or urethritis * Scheduled to receive radiation treatment to the vicinity, or history of radiation treatment to the urethra or adjacent structures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Experienced Biopsy Procedure-related Adverse Events | at biopsy or between biopsy and treatment, approximately 6 weeks | Biopsy was required to generate AMDC products. Biopsy procedure-related events were defined as systemic responses to the biopsy procedure or injury at the biopsy site. Since biopsy occurred prior to AMDC treatment, results are presented independent of AMDC dose received. All biopsy procedure-related events either self-resolved or were easily treated. |
| Number of Participants That Experienced Injection Procedure-related Adverse Events | 30 days | AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received. All injection procedure-related events self-resolved or were easily treated. |
| Injection Procedure-related Adverse Events | 30 days | AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received. All injection procedure-related events self-resolved or were easily treated. |
| Number of Participants That Experienced AMDC Product-related Events | 12 months | If an immune response after injection or any urinary retention occurred and seemed suspicious, the physicians were consulted to determine whether the effect was likely related to the AMDC product. No adverse events reported during the study were adjudicated as AMDC product-related. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Autologous Muscle-Derived Cells (AMDC) Intrasphincteric injection of 200 million AMDC for treatment of SUI in women | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Autologous Muscle-Derived Cells (AMDC) |
|---|---|
| Age, Continuous | 61 years STANDARD_DEVIATION 2 |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 12 / 16 |
| serious Total, serious adverse events | 1 / 16 |
Outcome results
Primary
Injection Procedure-related Adverse Events
AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received. All injection procedure-related events self-resolved or were easily treated.
Time frame: 30 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Autologous Muscle-Derived Cells (AMDC) | Injection Procedure-related Adverse Events | Abdominal pain lower | 2 events |
| Autologous Muscle-Derived Cells (AMDC) | Injection Procedure-related Adverse Events | Dysuria | 4 events |
| Autologous Muscle-Derived Cells (AMDC) | Injection Procedure-related Adverse Events | Micturition urgency | 1 events |
| Autologous Muscle-Derived Cells (AMDC) | Injection Procedure-related Adverse Events | Urinary tract infection | 1 events |
Primary
Number of Participants That Experienced AMDC Product-related Events
If an immune response after injection or any urinary retention occurred and seemed suspicious, the physicians were consulted to determine whether the effect was likely related to the AMDC product. No adverse events reported during the study were adjudicated as AMDC product-related.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Autologous Muscle-Derived Cells (AMDC) | Number of Participants That Experienced AMDC Product-related Events | 0 participants |
Primary
Number of Participants That Experienced Biopsy Procedure-related Adverse Events
Biopsy was required to generate AMDC products. Biopsy procedure-related events were defined as systemic responses to the biopsy procedure or injury at the biopsy site. Since biopsy occurred prior to AMDC treatment, results are presented independent of AMDC dose received. All biopsy procedure-related events either self-resolved or were easily treated.
Time frame: at biopsy or between biopsy and treatment, approximately 6 weeks
Population: One patient experienced procedural dizziness.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Autologous Muscle-Derived Cells (AMDC) | Number of Participants That Experienced Biopsy Procedure-related Adverse Events | 1 participants |
Primary
Number of Participants That Experienced Injection Procedure-related Adverse Events
AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received. All injection procedure-related events self-resolved or were easily treated.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Autologous Muscle-Derived Cells (AMDC) | Number of Participants That Experienced Injection Procedure-related Adverse Events | 6 participants |