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This randomized, double-blind, placebo-controlled, multicenter, confirmatory study will evaluate the efficacy and safety of Cook MyoSite Incorporated Autologous Muscle-Derived Cells (generic name Iltamiocel) compared to a placebo (vehicle) control dose in the treatment of stress urinary incontinence (SUI) in adult female patients.
Study comparing intrasphincteric injection of iltamiocel with placebo. Subjects unblinded after 12 month visits, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo control is the vehicle solution used for the study product. |
|
| Iltamiocel | Experimental | AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10^6 cells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Placebo control is the vehicle solution used for the study product. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With ≥ 50% Reduction in Stress Incontinence Episode Frequency From Baseline to 12 Months Post-treatment; as Assessed by 3 Day Diary | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With at ≥ 75% Reduction in Stress Incontinence Episodes From Baseline at 12 Months | Baseline and 12 months | |
| Participants With 0 or 1 Stress Incontinence Episodes Based on 3 Day Diary Records at 12 Months | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Association of Change in Quality of Life Scores With Change in Stress Incontinence Episode Frequency | Spearman's correlation used for analysis | Baseline and 12 months |
| Treatment Durability at 24 Months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Kaufman, M.D., Ph.D. | Vanderbilt University Medical Center, Department of Urologic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona Phoenix Campus | Phoenix | Arizona | 85054 | United States | ||
| The American Association of Female Pelvic Medicine Specialists |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39282854 | Derived | Kaufman MR, Goldman HB, Chermansky CJ, Dmochowski R, Kennelly MJ, Peters KM, Quiroz LH, Bennett JB, Thomas S, Marguet CG, Benson KD, Lee UJ, Sokol ER, Wolter CE, Katz DM, Tarnay CM, Antosh D, Heit MH, Rehme C, Karram M, Snyder S, Canestrari E, Jankowski RJ, Chancellor MB. Iltamiocel Autologous Cell Therapy for the Treatment of Female Stress Urinary Incontinence: A Double-Blind, Randomized, Stratified, Placebo-Controlled Trial. Neurourol Urodyn. 2024 Nov;43(8):2290-2299. doi: 10.1002/nau.25588. Epub 2024 Sep 16. | |
| 28734829 |
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311 subjects were enrolled (underwent biopsy procedure) and 297 subjects underwent study treatment with iltamiocel (199 subjects) or placebo (98 subjects). Analysis population is based on 297 subjects that underwent study treatment. At randomization, participants stratified by presence or absence of prior incontinence surgery and by < 10 or ≥10 stress incontinence episodes over 3 day diary at screening.
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| ID | Title | Description |
|---|---|---|
| FG000 | Iltamiocel | AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10^6 cells. |
| FG001 | Placebo | Placebo control is the vehicle solution used for the study product. Single intraurethral injection of vehicle control. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-Blind Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 18, 2016 |
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| Iltamiocel |
| Biological |
AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10^6 cells. |
|
|
| Change in the Frequency of Stress Incontinence Episodes From Baseline at 12 Months | Baseline and 12 months |
Treatment durability defined as iltamiocel-treated participants with reduction in stress incontinence episode frequency (SIEF) at 12 months who maintained that response at 24 months
| Baseline, 12 months, and 24 months after injection with iltamiocel |
| Agoura Hills |
| California |
| 91301 |
| United States |
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90024 | United States |
| Stanford University | Stanford | California | 94304 | United States |
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States |
| Emory University | Atlanta | Georgia | 30033 | United States |
| NorthShore University HealthSystem | Skokie | Illinois | 60076 | United States |
| IU Health Physicians Urogynecology | Indianapolis | Indiana | 46202 | United States |
| Female Pelvic Medicine & Urogynecology Institute of Michigan | Grand Rapids | Michigan | 49503 | United States |
| Mercy Health Saint Mary's Campus | Grand Rapids | Michigan | 49503 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| NYU Urology Associates | New York | New York | 10016 | United States |
| Premier Medical Group of the Hudson Valley PC | Poughkeepsie | New York | 12601 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| McKay Urology | Charlotte | North Carolina | 28207 | United States |
| The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital | Cincinnati | Ohio | 45242 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Greenville Health System | Greenville | South Carolina | 29607 | United States |
| Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic | Sioux Falls | South Dakota | 57105 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Methodist Urology Associates | Houston | Texas | 77030 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
| Benaroya Research Institute at Virginia Mason | Seattle | Washington | 98101 | United States |
| University Hospital Leuven | Leuven | 3000 | Belgium |
| Universitätsklinikum Essen | Essen | 45147 | Germany |
| Praxisklinik Urologie Rhein-Ruhr (PUR/R) | Mülheim | 45468 | Germany |
| Derived |
| Antosh DD, High R, Brown HW, Oliphant SS, Abed H, Philip N, Grimes CL. Feasibility of prophylactic salpingectomy during vaginal hysterectomy. Am J Obstet Gynecol. 2017 Nov;217(5):605.e1-605.e5. doi: 10.1016/j.ajog.2017.07.017. Epub 2017 Jul 20. |
| Injection |
|
| 1 Month Follow-Up |
|
| 3 Month Follow-Up |
|
| 6 Month Follow-Up |
|
| 12 Month Follow-Up |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
| Open Label - Unblinded Period |
|
|
Women ≥18 years or older with stress-predominant urinary incontinence.
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| ID | Title | Description |
|---|---|---|
| BG000 | Iltamiocel | AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10^6 cells. |
| BG001 | Placebo | Placebo control is the vehicle solution used for the study product. Single intraurethral injection of vehicle control. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Stress Incontinence Episodes Over 3 Day Diary | Participant recorded number of stress leaks over 3 days in electronic diary. | Mean | Standard Deviation | stress leaks |
| ||||||||||||||
| 24 Hour Pad Test Weight | A test in which the participant wears specific absorbent pads dispensed by the clinic. The pads are weighed to record the pre-test weight prior to dispensing to the participant. The participant must wear the absorbent pads for 24 hours. The participant returns the used absorbent pads to the clinic, and the clinic records the post-test weight to determine urinary leakage for the 24 hour period. The difference in weights represent the amount of urine leaked in which 24 hour pad weight = total weight of pads after test period - total weight of pads prior to test period. | Mean | Standard Deviation | grams |
| ||||||||||||||
| Incontinence Quality of Life (IQOL) Assessment -Total Score | The I-QOL questionnaire is a validated, 22-item tool used to assess quality of life (QOL) of women with urinary incontinence, focused on avoidance and limiting behavior, psychosocial impacts, and social embarrassment. Score scale is 0-100; increased score indicates improvement.. Scored 0 to100, with higher scores indicating a better QOL | Mean | Standard Deviation | scores on scales |
| ||||||||||||||
| 7-Item Incontinence Impact Questionnaire - Short Form (IIQ-7) | The IIQ-7 questionnaire is a validated, 7-item tool used to assess the impact of urinary incontinence on health-related quality of life, focused on physical activity, social relationships, travel, and emotional health. Scored 0 to 100, lower scores indicate better quality of life (QOL). | Mean | Standard Deviation | scores on scales |
| ||||||||||||||
| 6-Item Urogenital Distress Inventory Score - Short Form (UDI-6) | This questionnaire consists of 6 questions focused on symptoms related to stress urinary incontinence, detrusor overactivity, and bladder outlet obstruction. Score scale is 0-75; decreased score indicates improvement. | Mean | Standard Deviation | scores on scales |
| ||||||||||||||
| Global Quality of Life Assessment (GQOL) | This questionnaire consists of 1 question focused on satisfaction with condition. Score scale is 0-6; decreased score indicates improvement. | Mean | Standard Deviation | scores on scales |
| ||||||||||||||
| Incontinence Severity Index (ISI) | The ISI is a questionnaire consisting of two questions which assesses the frequency and quantity of urine leakage. Score scale is 0-12; decreased score indicates improvement. | Mean | Standard Deviation | scores on scales |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participants With ≥ 50% Reduction in Stress Incontinence Episode Frequency From Baseline to 12 Months Post-treatment; as Assessed by 3 Day Diary | All participants with baseline and 12 month 3 day diary data | Posted | Count of Participants | Participants | Baseline and 12 months |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Participants With at ≥ 75% Reduction in Stress Incontinence Episodes From Baseline at 12 Months | All participants with baseline and 12 month 3 day diary data | Posted | Count of Participants | Participants | Baseline and 12 months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Participants With 0 or 1 Stress Incontinence Episodes Based on 3 Day Diary Records at 12 Months | All participants with baseline and 12 month diary data | Posted | Count of Participants | Participants | Baseline and 12 months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Change in the Frequency of Stress Incontinence Episodes From Baseline at 12 Months | All participants with baseline and 12 month 3 day diary data | Posted | Mean | Standard Deviation | stress leaks | Baseline and 12 months |
|
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Association of Change in Quality of Life Scores With Change in Stress Incontinence Episode Frequency | Spearman's correlation used for analysis | All participants with baseline and 12 month diary data | Posted | Number | correlation coefficient | Baseline and 12 months |
|
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Treatment Durability at 24 Months | Treatment durability defined as iltamiocel-treated participants with reduction in stress incontinence episode frequency (SIEF) at 12 months who maintained that response at 24 months | All participants who received iltamiocel treatment during the double-blind period and with 12-month and 24-month stress incontinence episode frequency (SIEF) diary data. Participants who received placebo treatment in the double-blind period are not included due to receiving iltamiocel treatment in the open-label period after unblinding or were exited from the study. | Posted | Count of Participants | Participants | Baseline, 12 months, and 24 months after injection with iltamiocel |
|
| ||||||||||||||||||||||||||||||
| Post-Hoc | Participants With at ≥ 75% Reduction in Stress Incontinence Episodes From Baseline at 12 Months (Prior Surgery Participants Only) | Participants with a history of prior SUI surgery with baseline and 12 month diary data. | Posted | Count of Participants | Participants | Baseline and 12 months |
|
| |||||||||||||||||||||||||||||||
| Post-Hoc | Participants With 0 or 1 Stress Incontinence Episodes Based on 3 Day Diary Records at 12 Months (Prior Surgery Participants Only) | Participants with a history of prior SUI surgery with baseline and 12 month diary data. | Posted | Count of Participants | Participants | Baseline and 12 months |
|
| |||||||||||||||||||||||||||||||
| Post-Hoc | Change in the Frequency of Stress Incontinence Episodes From Baseline at 12 Months (Prior Surgery Participants Only) | Participants with a history of prior SUI surgery with baseline and 12 month diary data. | Posted | Mean | Standard Deviation | stress leaks | Baseline and 12 months |
|
| ||||||||||||||||||||||||||||||
| Post-Hoc | Association of Change in Quality of Life Scores With Change in Stress Incontinence Episode Frequency (Prior Surgery Participants Only) | Spearman's correlation used for analysis | All participants with prior surgery and baseline and 12 month diary data | Posted | Number | correlation coefficient | Baseline and 12 months |
|
| ||||||||||||||||||||||||||||||
| Post-Hoc | Treatment Durability at 24 Months (Prior Surgery Participants) | Treatment durability defined as participants with reduction in stress incontinence episode frequency (SIEF) at 12 months who maintained response at 24 months | Prior surgery participants who received iltamiocel treatment during the double-blind period with 12-month and 24-month stress incontinence episode frequency (SIEF) diary data. Prior surgery participants who received placebo treatment in the double-blind period are not included due to receiving iltamiocel treatment in the open-label period after unblinding or were exited from the study. | Posted | Count of Participants | Participants | Baseline, 12 months, and 24 months after injection with iltamiocel |
|
|
12 month double-blind period and open label unblinded period from month 12 to 24
Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Iltamiocel - Double-Blind Period | AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10^6 cells. | 0 | 199 | 11 | 199 | 84 | 199 |
| EG001 | Placebo - Double-Blind Period | Placebo control is the vehicle solution used for the study product. Single intraurethral injection of vehicle control. | 0 | 98 | 9 | 98 | 28 | 98 |
| EG002 | Iltamiocel - Unblinded Period | Subjects who received iltamiocel in double-blind period. No additional treatment for iltamiocel arm in unblinded period. | 0 | 198 | 12 | 198 | 21 | 198 |
| EG003 | Placebo Receiving Open Label Iltamiocel in Unblinded Period | Subjects who received placebo in double-blind period and elected to receive iltamiocel injection in unblinded period. Single intraurethral injection of 150 x 10^6 cells. | 0 | 92 | 4 | 92 | 22 | 92 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Coronary artery dissection | Cardiac disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA version 16.1 | Systematic Assessment | Related to Iltamiocel and Injection Procedure |
|
| Sepsis | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA version 16.1 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA version 16.1 | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 16.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA version 16.1 | Systematic Assessment | Related to Biopsy Procedure |
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| Coronary artery disease | Cardiac disorders | MedDRA version 16.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA version 16.1 | Systematic Assessment |
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| Bacteremia | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA version 16.1 | Systematic Assessment |
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| Intentional Overdose | Injury, poisoning and procedural complications | MedDRA version 16.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA version 16.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 16.1 | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 16.1 | Systematic Assessment |
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| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Joint lock | Musculoskeletal and connective tissue disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 16.1 | Systematic Assessment |
| |
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 16.1 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 16.1 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 16.1 | Systematic Assessment |
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| Panic attack | Psychiatric disorders | MedDRA version 16.1 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA version 16.1 | Systematic Assessment |
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| Malignant hypertension | Vascular disorders | MedDRA version 16.1 | Systematic Assessment |
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| Subgaleal haematoma | Vascular disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA version 16.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ron Jankowski, PhD | Cook MyoSite, Inc. | 412-963-7380 | Ron.Jankowski@CookMyosite.com |
| Aug 5, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Withdrawal by Subject |
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| Adverse Event |
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| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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| United States |
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| Germany |
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