Stress Urinary Incontinence
Conditions
Brief summary
Determine safety and effectiveness of the technique using autologous stem cells in the treatment of urinary incontinence in one male subject.
Detailed description
Autologous stem cells will be obtained from the subject by needle biopsy, sent to a lab for multiplication and after about 6 weeks time will be injected into the subjects urethra.
Interventions
PROCEDUREMuscle Biopsy
Biopsy of thigh muscle to obtain stem cell core.
BIOLOGICALInjection of autologous stem cells
After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra.
Sponsors
Corewell Health East
Kenneth Peters, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
78 Years to 82 Years
Healthy volunteers
No
Inclusion criteria
* urinary incontinence * failed urinary incontinence (UI) treatments
Exclusion criteria
\- does not meet inclusion criteria, gender and age limit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study-Related Adverse Events | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (QOL) Described by the Patient's Response on the Patient Global Assessment of Severity (PGI-S) Questionnaire | Baseline and 6 months | The PGI-S is comprised of two questions. Question 1 asks the patient to describe how their urinary tract condition is now. Responses are 1 Normal, 2 Mild, 3 Moderate and 4 Severe. Question 2 asks the patient If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Responses are 1 Delighted, 2 Pleased, 3 Mostly Satisfied, 4 Mixed, 5 Mostly Dissatisfied, 6 Unhappy and 7 Terrible. |
| Quality of Life (QOL) Described by the Patient's Response on the Global Response Assessment (GRA) | 6 months | The GRA measures overall improvement with therapy. The patient's response describes their current condition compared to before they were treated. Responses are: 1 Markedly Improved, 2 Moderately Improved, 3 Slightly Improved, 4 No Change, 5 Slightly Worse, 6 Moderately Worse, and 7 Markedly Worse. |
| Quality of Life (QOL) Described by the Patient's Response on the Patient Global Impression of Improvement (PGI-I) | 6 months | The PGI-I is a global index used to rate the response of a condition to a therapy. The patient's response describes their current condition compared to before they were treated. Responses are: 1 Very Much Better, 2 Much Better, 3 A Little Better, 4 No Change, 5 A Little Worse, 6 Much Worse, and 7 Very Much Worse. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stem Cell Treatment Muscle Biopsy and Injection of autologous stem cells
Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core.
Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Stem Cell Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Gender Female | 0 Participants |
| Gender Male | 1 Participants |
| Region of Enrollment United States | 1 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Study-Related Adverse Events
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stem Cell Treatment | Study-Related Adverse Events | 0 Adverse Events |
Secondary
Quality of Life (QOL) Described by the Patient's Response on the Global Response Assessment (GRA)
The GRA measures overall improvement with therapy. The patient's response describes their current condition compared to before they were treated. Responses are: 1 Markedly Improved, 2 Moderately Improved, 3 Slightly Improved, 4 No Change, 5 Slightly Worse, 6 Moderately Worse, and 7 Markedly Worse.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stem Cell Treatment | Quality of Life (QOL) Described by the Patient's Response on the Global Response Assessment (GRA) | 4 units on a scale |
Secondary
Quality of Life (QOL) Described by the Patient's Response on the Patient Global Assessment of Severity (PGI-S) Questionnaire
The PGI-S is comprised of two questions. Question 1 asks the patient to describe how their urinary tract condition is now. Responses are 1 Normal, 2 Mild, 3 Moderate and 4 Severe. Question 2 asks the patient If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Responses are 1 Delighted, 2 Pleased, 3 Mostly Satisfied, 4 Mixed, 5 Mostly Dissatisfied, 6 Unhappy and 7 Terrible.
Time frame: Baseline and 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stem Cell Treatment | Quality of Life (QOL) Described by the Patient's Response on the Patient Global Assessment of Severity (PGI-S) Questionnaire | Question 1: Baseline Score | 4 units on a scale |
| Stem Cell Treatment | Quality of Life (QOL) Described by the Patient's Response on the Patient Global Assessment of Severity (PGI-S) Questionnaire | Question 1: 6 Months Post-Injection Score | 4 units on a scale |
| Stem Cell Treatment | Quality of Life (QOL) Described by the Patient's Response on the Patient Global Assessment of Severity (PGI-S) Questionnaire | Question 2: Baseline Score | 5 units on a scale |
| Stem Cell Treatment | Quality of Life (QOL) Described by the Patient's Response on the Patient Global Assessment of Severity (PGI-S) Questionnaire | Question 2: 6 Months Post-Injection Score | 6 units on a scale |
Secondary
Quality of Life (QOL) Described by the Patient's Response on the Patient Global Impression of Improvement (PGI-I)
The PGI-I is a global index used to rate the response of a condition to a therapy. The patient's response describes their current condition compared to before they were treated. Responses are: 1 Very Much Better, 2 Much Better, 3 A Little Better, 4 No Change, 5 A Little Worse, 6 Much Worse, and 7 Very Much Worse.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stem Cell Treatment | Quality of Life (QOL) Described by the Patient's Response on the Patient Global Impression of Improvement (PGI-I) | 4 units on a scale |