Lower Urinary Tract Symptoms, Stress, Urinary Incontinence, Urination Disorders, Urological Manifestations, Urologic Diseases
Conditions
Keywords
Urinary Incontinence, Stress, Tissue Therapy (Cell Therapy)
Brief summary
To study the safety and potential efficacy of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of male stress urinary incontinence (SUI) for patients that have undergone prior prostate surgery.
Detailed description
This preliminary, prospective, single-arm clinical study will evaluate the safety and potential efficacy of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of male stress urinary incontinence (SUI) that develops following prostate surgery.
Interventions
BIOLOGICALautologous muscle-derived cells (AMDC)
Cell treatment
Sponsors
Cook MyoSite
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male, at least 18 years old, with primary symptoms of SUI following prostate surgery, * Patient has undergone prostate surgery but has not undergone radiation therapy, cryotherapy, or high-intensity focused ultrasound of the prostate, * SUI severity should be ≥10 g and \<400 g of urine leakage over 24 hours, * Patient has failed to achieve acceptable resolution of SUI symptoms following prior therapy.
Exclusion criteria
* Symptoms of only urge urinary incontinence, * Symptoms of stress urinary incontinence prior to prostate surgery, * Routinely has more than 2 episodes of awakening to void during normal sleeping hours, * Compromised immune system due to disease state, chronic corticosteroid use, or other immunosuppressive therapy, * Previously treated with a periurethral balloon or adjustable sling for urinary incontinence, * Symptoms of overflow incontinence * Additional medical restrictions as specified in the Clinical Investigation Plan, * Additional anatomical restrictions as specified in the Clinical Investigation Plan.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Product-related, Biopsy Procedure-related, and Injection Procedure-related Adverse Events | 24 months | Safety of AMDC-USR following treatment of SUI in male patients who have undergone prior prostate surgery was determined by the frequency and severity of adverse events related to study procedures and study product through 24 months following treatment of SUI in male patients who have undergone prior prostate surgery. |
| Volume of Post-void Residual (PVR) Urine | 1, 3, 6, and 12 months | Post void residual volume (PVR) was assessed through 12 months post-treatment to monitor potential retention or obstruction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Change From Baseline in Patient-reported Quality of Life (QOL) - Incontinence Quality of Life (I-QOL) Questionnaire | 1, 3, 6, and 12 months | Median change from baseline in patient-reported quality of life (QOL) was assessed by the Incontinence Quality of Life (I-QOL) questionnaire at 1, 3, 6 and 12 months post-treatment. The I-QOL questionnaire was a validated, 22-item tool used to assess QOL of participants with urinary incontinence. Scored 0 to100, with higher scores indicating a better QOL. |
| Median Change From Baseline in Patient-reported Symptom Severity- International Consultation on Incontinence Questionnaire (ICIQ) | Baseline, 1, 3, 6, and 12 months | Median change from baseline in patient-reported symptom severity was assessed by the International Consultation on Incontinence Questionnaire (ICIQ) questionnaire at 1, 3, 6, and 12 months post-treatment. The ICIQ questionnaire was a validated 4-item tool used to assess symptom severity of participants with urinary incontinence. Scored 0 to 21, with lower scores indicating a better symptom severity. |
| Median Change in Patient-reported Incontinence Symptom Severity - International Prostate Symptom Score (I-PSS) Questionnaire | Baseline, 1, 3, 6, and 12 months | Patient-reported incontinence symptom severity was assessed by questionnaires at 1, 3, 6, and 12 months post-treatment using the International Prostate Symptom Score (I-PSS) questionnaire. The I-PSS was a validated questionnaire used to assess the severity of three urine storage symptoms (frequency, nocturia, urgency), four voiding symptoms (feeling of incomplete emptying, intermittency, straining, and a weak stream) and the degree of bother associated with those symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms, and 20 to 35 indicates severe symptoms. |
| Change From Baseline in Amount of Urine Leakage (Median 24 Hour Pad Weight) | 1, 3, 6, and 12 months | Change in the amount of urine leakage from baseline was assessed by 24-hour pad test at 1, 3, 6, and 12 months post-treatment. Amount of urine leakage experienced by subject at home during a 24-hour period; all pads used during test period are weighed before and after use and differences in weights represent the amount of urine leaked. |
| Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire | 1, 3, 6, and 12 months | Patient-reported incontinence symptom severity was assessed by questionnaires at 1, 3, 6, and 12 months post-treatment using the Patient Global Impression of Improvement (PGI-I) questionnaire. The PGI-I was a global assessment of symptom severity in which participants selected the following ratings: 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. Percentages of participants in each category were determined at each visit. |
| Median Change From Baseline in Patient-reported Erectile Dysfunction (ED) - Index of Erectile Function (IIEF-5) Questionnaire | Baseline, 1, 3, 6, and 12 months | SUI and ED can be comorbidities that develop following prostate surgery; median change from baseline in patient-reported Erectile Dysfunction (ED) was assessed by the 5-Item International Index of Erectile Function (IIEF-5). The IIEF-5 questionnaire was a validated 5-item tool used to assess to presence and severity of erectile dysfunction. Scored from 5 to 25, with lower scores indicating less ED symptoms. |
| Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire | 1, 3, 6, and 12 months | Patient-reported incontinence symptom severity was assessed by questionnaires at 1, 3, 6, and 12 months post-treatment using the Patient Global Impression of Severity (PGI-S) questionnaire. The PGI-S was a global assessment of symptom severity compared with severity before treatment started. Ratings that could be selected were: 1-normal, 2-mild, 3-moderate, and 4-severe. Percentages of participants in each category were determined at each visit. |
| Number of Participants With a Change From Baseline in Amount of Urine Leakage (Categorial ≥50% Reduction in 24-hour Pad Weight) | 1, 3, 6, and 12 months | Change in the amount of urine leakage from baseline was assessed by a 24-hour pad test at 1, 3, 6, and 12 months post-treatment. Amount of urine leakage experienced by subject at home during a 24-hour period; all pads used during test period are weighed before and after use and differences in weights represent the amount of urine leaked. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AMDC-USR Single intraurethral injection of 150 x 10\^6 autologous muscle-derived cells (AMDCs). | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | AMDC-USR |
|---|---|
| 24-hour Pad Test Weight | 109.1 grams |
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 17 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 67 years |
| Age, Customized Participant Age | 67.2 years STANDARD_DEVIATION 5.8 |
| Incontinence Quality of Life (I-QOL) | 59.1 scores on scales |
| International Consultation on Incontinence Questionnaire (ICIQ) | 13 scores on scales |
| International Index of Erectile Function (IIEF) | 13 scores on scales |
| International Prostate Symptom Score (IPSS) | 9 scores on scales |
| Patient Global Impression of Severity (PGI-S) Questionnaire Mild | 8 Participants |
| Patient Global Impression of Severity (PGI-S) Questionnaire Moderate | 13 Participants |
| Patient Global Impression of Severity (PGI-S) Questionnaire Normal | 0 Participants |
| Patient Global Impression of Severity (PGI-S) Questionnaire Severe | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Region of Enrollment United States | 25 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 25 Participants |
| Urinary Incontinence Type Mixed Urinary Incontinence, Stress Predominant | 17 Participants |
| Urinary Incontinence Type Mixed Urinary Incontinence, Urge Predominant | 4 Participants |
| Urinary Incontinence Type Pure Stress Urinary Incontinence | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 9 / 25 |
| serious Total, serious adverse events | 4 / 25 |
Outcome results
Primary
Rate of Product-related, Biopsy Procedure-related, and Injection Procedure-related Adverse Events
Safety of AMDC-USR following treatment of SUI in male patients who have undergone prior prostate surgery was determined by the frequency and severity of adverse events related to study procedures and study product through 24 months following treatment of SUI in male patients who have undergone prior prostate surgery.
Time frame: 24 months
Population: All subjects enrolled (biopsied)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AMDC-USR | Rate of Product-related, Biopsy Procedure-related, and Injection Procedure-related Adverse Events | Study product-related serious adverse events | 0 events |
| AMDC-USR | Rate of Product-related, Biopsy Procedure-related, and Injection Procedure-related Adverse Events | Study Product-related adverse events | 2 events |
| AMDC-USR | Rate of Product-related, Biopsy Procedure-related, and Injection Procedure-related Adverse Events | Injection procedure-related adverse events | 0 events |
| AMDC-USR | Rate of Product-related, Biopsy Procedure-related, and Injection Procedure-related Adverse Events | Biopsy procedure-related adverse events | 12 events |
Primary
Volume of Post-void Residual (PVR) Urine
Post void residual volume (PVR) was assessed through 12 months post-treatment to monitor potential retention or obstruction.
Time frame: 1, 3, 6, and 12 months
Population: All subjects injected
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AMDC-USR | Volume of Post-void Residual (PVR) Urine | Post void residual volume 1 month | 0 millileters |
| AMDC-USR | Volume of Post-void Residual (PVR) Urine | Post void residual volume 3 months | 0 millileters |
| AMDC-USR | Volume of Post-void Residual (PVR) Urine | Post void residual volume 6 months | 0 millileters |
| AMDC-USR | Volume of Post-void Residual (PVR) Urine | Post void residual volume 12 months | 0 millileters |
Secondary
Change From Baseline in Amount of Urine Leakage (Median 24 Hour Pad Weight)
Change in the amount of urine leakage from baseline was assessed by 24-hour pad test at 1, 3, 6, and 12 months post-treatment. Amount of urine leakage experienced by subject at home during a 24-hour period; all pads used during test period are weighed before and after use and differences in weights represent the amount of urine leaked.
Time frame: 1, 3, 6, and 12 months
Population: All subjects injected
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AMDC-USR | Change From Baseline in Amount of Urine Leakage (Median 24 Hour Pad Weight) | 24 hour pad weight at 1 month | 101.2 grams |
| AMDC-USR | Change From Baseline in Amount of Urine Leakage (Median 24 Hour Pad Weight) | 24 hour pad weight at 3 months | 59.5 grams |
| AMDC-USR | Change From Baseline in Amount of Urine Leakage (Median 24 Hour Pad Weight) | 24 hour pad weight at 6 months | 104.9 grams |
| AMDC-USR | Change From Baseline in Amount of Urine Leakage (Median 24 Hour Pad Weight) | 24 hour pad weight at 12 months | 85.7 grams |
Secondary
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire
Patient-reported incontinence symptom severity was assessed by questionnaires at 1, 3, 6, and 12 months post-treatment using the Patient Global Impression of Improvement (PGI-I) questionnaire. The PGI-I was a global assessment of symptom severity in which participants selected the following ratings: 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. Percentages of participants in each category were determined at each visit.
Time frame: 1, 3, 6, and 12 months
Population: All subjects injected
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire | PGI-I score at 1 month | Very much better | 1 Participants |
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire | PGI-I score at 1 month | Much better | 0 Participants |
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire | PGI-I score at 1 month | A little better | 4 Participants |
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire | PGI-I score at 1 month | No change | 18 Participants |
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire | PGI-I score at 1 month | A little worse | 0 Participants |
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire | PGI-I score at 3 months | Very much better | 0 Participants |
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire | PGI-I score at 3 months | Much better | 1 Participants |
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire | PGI-I score at 3 months | A little better | 12 Participants |
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire | PGI-I score at 3 months | No change | 9 Participants |
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire | PGI-I score at 3 months | A little worse | 1 Participants |
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire | PGI-I score at 6 months | Very much better | 0 Participants |
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire | PGI-I score at 6 months | Much better | 3 Participants |
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire | PGI-I score at 6 months | A little better | 11 Participants |
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire | PGI-I score at 6 months | No change | 7 Participants |
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire | PGI-I score at 6 months | A little worse | 2 Participants |
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire | PGI-I score at 12 months | Very much better | 0 Participants |
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire | PGI-I score at 12 months | Much better | 4 Participants |
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire | PGI-I score at 12 months | A little better | 11 Participants |
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire | PGI-I score at 12 months | No change | 5 Participants |
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire | PGI-I score at 12 months | A little worse | 3 Participants |
Secondary
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire
Patient-reported incontinence symptom severity was assessed by questionnaires at 1, 3, 6, and 12 months post-treatment using the Patient Global Impression of Severity (PGI-S) questionnaire. The PGI-S was a global assessment of symptom severity compared with severity before treatment started. Ratings that could be selected were: 1-normal, 2-mild, 3-moderate, and 4-severe. Percentages of participants in each category were determined at each visit.
Time frame: 1, 3, 6, and 12 months
Population: All subjects injected
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire | PGI-S score at 1 month | Normal | 1 Participants |
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire | PGI-S score at 1 month | Mild | 3 Participants |
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire | PGI-S score at 1 month | Moderate | 13 Participants |
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire | PGI-S score at 1 month | Severe | 6 Participants |
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire | PGI-S score at 3 months | Normal | 0 Participants |
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire | PGI-S score at 3 months | Mild | 8 Participants |
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire | PGI-S score at 3 months | Moderate | 12 Participants |
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire | PGI-S score at 3 months | Severe | 3 Participants |
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire | PGI-S score at 6 months | Normal | 0 Participants |
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire | PGI-S score at 6 months | Mild | 9 Participants |
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire | PGI-S score at 6 months | Moderate | 11 Participants |
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire | PGI-S score at 6 months | Severe | 3 Participants |
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire | PGI-S score at 12 months | Normal | 1 Participants |
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire | PGI-S score at 12 months | Mild | 6 Participants |
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire | PGI-S score at 12 months | Moderate | 13 Participants |
| AMDC-USR | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire | PGI-S score at 12 months | Severe | 3 Participants |
Secondary
Median Change From Baseline in Patient-reported Erectile Dysfunction (ED) - Index of Erectile Function (IIEF-5) Questionnaire
SUI and ED can be comorbidities that develop following prostate surgery; median change from baseline in patient-reported Erectile Dysfunction (ED) was assessed by the 5-Item International Index of Erectile Function (IIEF-5). The IIEF-5 questionnaire was a validated 5-item tool used to assess to presence and severity of erectile dysfunction. Scored from 5 to 25, with lower scores indicating less ED symptoms.
Time frame: Baseline, 1, 3, 6, and 12 months
Population: All subjects injected
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AMDC-USR | Median Change From Baseline in Patient-reported Erectile Dysfunction (ED) - Index of Erectile Function (IIEF-5) Questionnaire | Change in IEEF-5 score at 1 month | 0 scores on a scale |
| AMDC-USR | Median Change From Baseline in Patient-reported Erectile Dysfunction (ED) - Index of Erectile Function (IIEF-5) Questionnaire | Change in IEEF-5 score at 3 months | 0 scores on a scale |
| AMDC-USR | Median Change From Baseline in Patient-reported Erectile Dysfunction (ED) - Index of Erectile Function (IIEF-5) Questionnaire | Change in IEEF-5 score at 6 months | 0 scores on a scale |
| AMDC-USR | Median Change From Baseline in Patient-reported Erectile Dysfunction (ED) - Index of Erectile Function (IIEF-5) Questionnaire | Change in IEEF-5 score at 12 months | 0 scores on a scale |
Secondary
Median Change From Baseline in Patient-reported Quality of Life (QOL) - Incontinence Quality of Life (I-QOL) Questionnaire
Median change from baseline in patient-reported quality of life (QOL) was assessed by the Incontinence Quality of Life (I-QOL) questionnaire at 1, 3, 6 and 12 months post-treatment. The I-QOL questionnaire was a validated, 22-item tool used to assess QOL of participants with urinary incontinence. Scored 0 to100, with higher scores indicating a better QOL.
Time frame: 1, 3, 6, and 12 months
Population: All subjects injected
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AMDC-USR | Median Change From Baseline in Patient-reported Quality of Life (QOL) - Incontinence Quality of Life (I-QOL) Questionnaire | Change in I-QOL total score at 1 month | -6.8 points |
| AMDC-USR | Median Change From Baseline in Patient-reported Quality of Life (QOL) - Incontinence Quality of Life (I-QOL) Questionnaire | Change in I-QOL total score at 3 months | 0 points |
| AMDC-USR | Median Change From Baseline in Patient-reported Quality of Life (QOL) - Incontinence Quality of Life (I-QOL) Questionnaire | Change in I-QOL total score at 6 months | -9.1 points |
| AMDC-USR | Median Change From Baseline in Patient-reported Quality of Life (QOL) - Incontinence Quality of Life (I-QOL) Questionnaire | Change in I-QOL total score at 12 months | -9.1 points |
Secondary
Median Change From Baseline in Patient-reported Symptom Severity- International Consultation on Incontinence Questionnaire (ICIQ)
Median change from baseline in patient-reported symptom severity was assessed by the International Consultation on Incontinence Questionnaire (ICIQ) questionnaire at 1, 3, 6, and 12 months post-treatment. The ICIQ questionnaire was a validated 4-item tool used to assess symptom severity of participants with urinary incontinence. Scored 0 to 21, with lower scores indicating a better symptom severity.
Time frame: Baseline, 1, 3, 6, and 12 months
Population: All subjects injected
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AMDC-USR | Median Change From Baseline in Patient-reported Symptom Severity- International Consultation on Incontinence Questionnaire (ICIQ) | Change in ICIQ score at 1 month | 0 scores on a scale |
| AMDC-USR | Median Change From Baseline in Patient-reported Symptom Severity- International Consultation on Incontinence Questionnaire (ICIQ) | Change in ICIQ score at 3 months | 0 scores on a scale |
| AMDC-USR | Median Change From Baseline in Patient-reported Symptom Severity- International Consultation on Incontinence Questionnaire (ICIQ) | Change in ICIQ score at 6 months | 0 scores on a scale |
| AMDC-USR | Median Change From Baseline in Patient-reported Symptom Severity- International Consultation on Incontinence Questionnaire (ICIQ) | Change in ICIQ score at 12 months | 1 scores on a scale |
Secondary
Median Change in Patient-reported Incontinence Symptom Severity - International Prostate Symptom Score (I-PSS) Questionnaire
Patient-reported incontinence symptom severity was assessed by questionnaires at 1, 3, 6, and 12 months post-treatment using the International Prostate Symptom Score (I-PSS) questionnaire. The I-PSS was a validated questionnaire used to assess the severity of three urine storage symptoms (frequency, nocturia, urgency), four voiding symptoms (feeling of incomplete emptying, intermittency, straining, and a weak stream) and the degree of bother associated with those symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms, and 20 to 35 indicates severe symptoms.
Time frame: Baseline, 1, 3, 6, and 12 months
Population: All subjects injected
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AMDC-USR | Median Change in Patient-reported Incontinence Symptom Severity - International Prostate Symptom Score (I-PSS) Questionnaire | Change in I-PSS score at 1 month | 1 scores on a scale |
| AMDC-USR | Median Change in Patient-reported Incontinence Symptom Severity - International Prostate Symptom Score (I-PSS) Questionnaire | Change in I-PSS score at 3 months | 1 scores on a scale |
| AMDC-USR | Median Change in Patient-reported Incontinence Symptom Severity - International Prostate Symptom Score (I-PSS) Questionnaire | Change in I-PSS score at 6 months | 1 scores on a scale |
| AMDC-USR | Median Change in Patient-reported Incontinence Symptom Severity - International Prostate Symptom Score (I-PSS) Questionnaire | Change in I-PSS score at 12 months | 1 scores on a scale |
Secondary
Number of Participants With a Change From Baseline in Amount of Urine Leakage (Categorial ≥50% Reduction in 24-hour Pad Weight)
Change in the amount of urine leakage from baseline was assessed by a 24-hour pad test at 1, 3, 6, and 12 months post-treatment. Amount of urine leakage experienced by subject at home during a 24-hour period; all pads used during test period are weighed before and after use and differences in weights represent the amount of urine leaked.
Time frame: 1, 3, 6, and 12 months
Population: All subjects injected
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AMDC-USR | Number of Participants With a Change From Baseline in Amount of Urine Leakage (Categorial ≥50% Reduction in 24-hour Pad Weight) | ≥50% reduction in 24 hour pad weight at 1 month | 2 Participants |
| AMDC-USR | Number of Participants With a Change From Baseline in Amount of Urine Leakage (Categorial ≥50% Reduction in 24-hour Pad Weight) | ≥50% reduction in 24 hour pad weight at 3 months | 4 Participants |
| AMDC-USR | Number of Participants With a Change From Baseline in Amount of Urine Leakage (Categorial ≥50% Reduction in 24-hour Pad Weight) | ≥50% reduction in 24 hour pad weight at 6 months | 4 Participants |
| AMDC-USR | Number of Participants With a Change From Baseline in Amount of Urine Leakage (Categorial ≥50% Reduction in 24-hour Pad Weight) | ≥50% reduction in 24 hour pad weight at 12 months | 7 Participants |