Stress Urinary IncontinenceALTONCT06351579
Data Collection Post Radical Prostatectomy
An observational study of Stress Urinary Incontinence and Radical Prostatectomy, run by Levee Medical, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 70 years, men only
- Conditions the study is for
- Stress Urinary Incontinence, Radical Prostatectomy, BPH
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2023to 30 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Male 45-70 years of age
- Diagnosed with prostate cancer and scheduled for radical prostatectomy
- Gleason Grade Group 3 or lower
- Prostate size less than 80 grams
- Able and willing to provide written consent to participate in the study
- Able and willing to comply with study follow-up visits and procedures
Who cannot join
- Malignant tumors outside of the prostate capsule confirmed via baseline assessments (e.g., mpMRI, bone scan)
- History of urinary incontinence, including stress or urge urinary incontinence
- On medications to treat overactive bladder (OAB)
- Presence of urethral stricture or bladder neck contracture
- Current or chronic urinary tract infection
- Prior urologic outlet surgical or minimally invasive procedure (e.g., TURP, HoLEP, Rezum, etc.).
Show all 20Show fewer
- Prior pelvic radiation or anticipated need for radiation after radical prostatectomy
- Presence of stones in the bladder
- History of neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function
- Body mass index >35
- History of cancer (excluding prostate cancer meeting the inclusion criteria) which is not considered in complete remission - a potential participant is considered cured if there has been no evidence of cancer within five years of enrollment
- Diagnosed or suspected primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function, sphincter function or poor detrusor muscle function
- History of clinically significant congestive heart failure (i.e., New York Heart Association (NYHA) Class III and IV)
- Insulin-dependent diabetes mellitus
- Current uncontrolled diabetes (i.e., hemoglobin A1c ≥7.5%)
- Intravesical prostatic protrusion (IPP) >5mm
- History of immunosuppressive conditions (e.g., AIDS, post-transplant)
- Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study per investigator discretion
- Any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affect the ability to complete the study quality of life questionnaires
- Subject currently participating in other investigational studies unless approved by the Sponsor in writing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Look at Outcomes After Post Radical Prostatectomy
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.
Read the detailed description
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.
- Conditions
- Stress Urinary Incontinence, Radical Prostatectomy, BPH
- Being tested
- Control
- Keywords
- SUI, BPH, Prostatectomy
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
This is an observational (registry) study for data collection only. No device or intervention will be used in this study.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, post-foley, 6 weeks, 3 months, 6 months, and 12 months post-prostatectomy procedure.
Secondary outcomes (1)
Change in pad weight during a 1-hour provocative pad weight test
The 1-hour pad test involves the following:
- Subject puts on a pre-weighed pad and is asked to avoid voiding;
- Subject drinks 500 ml of sodium-free liquid in <15 minutes, then sits or rests;
- Subjects walks for 30 minutes, including climbing one flight of stairs (up and down)
- Subject performs the following activities: standing up from sitting (10x), coughing vigorously (10x), running on the spot for 1 minute, bending to pick up an object from the floor (5x), and washing hands in running water for 1 minute;
- The total amount of urine leaked is determined by weighing the pad. If voiding is urgent and unavoidable, the test is terminated. Collect voiding volume and repeat the test after re-hydration.
Measured: Baseline, post-foley, 6 weeks, 3 months, 6 months, and 12 months post-prostatectomy procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start30 Mar 2023
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Levee Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RQM+
- Responsible party
- Sponsor
- Investigators
- Bruce Choi, Study chair, Founder and CTO, Levee Medical, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351579
- Sponsor's protocol ID
- 1010159
- Acronym
- ALTO
- Status last verified
- Sep 2025
- First submitted
- 2 Apr 2024
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Look at Outcomes After Post Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT06351579
- Acronym / sponsor ID
- ALTO / 1010159
- Conditions
- Stress Urinary Incontinence, Radical Prostatectomy, BPH
- Keywords
- SUI, BPH, Prostatectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Levee Medical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- RQM+
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- Male 45-70 years of age
- Diagnosed with prostate cancer and scheduled for radical prostatectomy
- Gleason Grade Group 3 or lower
- Prostate size less than 80 grams
- Able and willing to provide written consent to participate in the study
Key exclusion criteria (20 listed)
- Malignant tumors outside of the prostate capsule confirmed via baseline assessments (e.g., mpMRI, bone scan)
- History of urinary incontinence, including stress or urge urinary incontinence
- On medications to treat overactive bladder (OAB)
- Presence of urethral stricture or bladder neck contracture
- Current or chronic urinary tract infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlThis is an observational (registry) study for data collection only. No device or intervention will be used in this study. | Other | – |
Primary outcome
The change in average 24-hour pad weight over time
Time frame: Baseline, post-foley, 6 weeks, 3 months, 6 months, and 12 months post-prostatectomy procedure.
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.
1 secondary outcome
Change in pad weight during a 1-hour provocative pad weight test
Time frame: Baseline, post-foley, 6 weeks, 3 months, 6 months, and 12 months post-prostatectomy procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Choi study chair
Founder and CTO, Levee Medical, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Urinary Incontinence and Radical Prostatectomy, run by Levee Medical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in average 24-hour pad weight over time (time frame: Baseline, post-foley, 6 weeks, 3 months, 6 months, and 12 months post-prostatectomy procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.