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| Name | Class |
|---|---|
| RQM+ | INDUSTRY |
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The study is designed to collect information on patients undergoing radical prostatectomy (RP), with a primary focus on the occurrence, duration, and severity of post-prostatectomy incontinence. Data will be collected at multiple time points, allowing for a dynamic understanding of urinary incontinence patterns at post RP.
Urinary incontinence (UI) is predominantly iatrogenic following radical prostatectomy (RP). Surgical removal of the prostate leads to a shortened urethra, widened bladder neck, and diminished urethral support. This results in increased demand on the urinary sphincter to maintain urinary continence. Most men will experience acute urinary incontinence following RP. Continence progressively improves over time; however, it is estimated that between 5-15% of men will experience chronic urinary incontinence.
Current treatments for post-prostatectomy urinary incontinence include conservative therapies such as pelvic floor muscle training and surgical treatments. The sponsor is conducting a feasibility study (ARID) using a medical device to improve / reduce UI rate at post-RP. This study (ALTO) is designed as a control cohort to collect information on patients undergoing radical prostatectomy (RP) without using the device.
This ALTO study is to systematically collect detailed information on patients undergoing radical prostatectomy, with a primary focus on the occurrence, duration, and severity of post-prostatectomy incontinence. Data will be collected at multiple time points, allowing for a dynamic understanding of urinary incontinence patterns at post RP.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Other | This is an observational (registry) study for data collection only. No device or intervention will be used in this study. |
| Measure | Description | Time Frame |
|---|---|---|
| The change in average 24-hour pad weight over time | The 24-hour (at-home) pad weight test - The pads are pre-weighed prior to providing them to subjects. The test should be started with an empty bladder. The subject will wear pads and perform their normal daily activities for 24 hours. The subject will be asked to change the pads approximately once every 6 hours during waking hours, or more frequently as needed. The pads will be stored in an air tight bag or container after removal, stored in a refrigerator, and brought to the site at the required follow-up visit for weighing. | Baseline, post-foley, 6 weeks, 3 months, 6 months, and 12 months post-prostatectomy procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pad weight during a 1-hour provocative pad weight test | The 1-hour pad test involves the following:
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| Measure | Description | Time Frame |
|---|---|---|
| Expanded Prostate Index Composite (EPIC-26) score. | The Expanded Prostate Cancer Index Composite is a validated, comprehensive questionnaire designed to evaluate patient function and bother after localized prostate cancer treatment. The questionnaire contains 13 items across 5 domains (i.e., urinary incontinence, urinary irritative/obstructive, bowel, sexual and hormonal). Response options for each item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better quality of life. |
Inclusion Criteria:
Exclusion Criteria:
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The study will enroll male subjects diagnosed with prostate cancer who are scheduled for radical prostatectomy. Subjects must meet all the inclusion criteria and none of the exclusion criteria to participate in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Choi | Founder and CTO, Levee Medical, Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LeeveMedical, Inc | Durham | North Carolina | 27703 | United States |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Baseline, post-foley, 6 weeks, 3 months, 6 months, and 12 months post-prostatectomy procedure. |
| Baseline, post-foley, 6 weeks, 3 months, 6 months, and 12 months post-prostatectomy procedure. |
| 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 |