Patients Susceptible to FallsNCT05183633
A Pilot Study to Assess the Association Between Human Bioimpedance Measurements and Clinical Urodynamic Procedures
An observational study of Patients Susceptible to Falls, run by Curbell Medical Products, Inc. at 1 site in United States.
Trial summary
A Pilot Study to Assess the Association between Human Bioimpedance Measurements and Clinical Urodynamic Procedures Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Patients Susceptible to Falls
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2022to 3 Feb 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients that have been previously scheduled for a urodynamic study
Who may be able to join
- Patients that have been previously scheduled for a Urodynamic Study
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Western New York Urology Associates
Cheektowaga, New York, 14225
About this study
A Pilot Study to Assess the Association between Human Bioimpedance Measurements and Clinical Urodynamic Procedures
Read the detailed description
The purpose of the study is to assess how well Curbell's Bladder Sensor device measuring bioimpedance correlates to urodynamic studies and the reported sensation subjects feel when reporting bladder fullness and their urge to urinate.
- Conditions
- Patients Susceptible to Falls
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| One single trial | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of Urge to Urinate to Bioimpedance. Our clinical trial is an attempt to determine the correlation of bioimpedance measurements versus bladder pressure (fullness) taken at the same time during a normally scheduled urodynamic study.
Our primary outcome is determining the correlation strength between the bladder's pressure measurements (acquired during a standard urodynamic study) and bioimpedance measurements. That is, we are trying to find if bladder bioimpedance is correlated to bladder fullness, where pressure is the clinically-accepted measurement of bladder fullness in a urodynamic study.
Measured: Bioimpedance measurements are taken in real time simultaneously with urodynamic pressure measurements. Therefore, the time frame is "zero." Each measurement characterizes actual bioimpedance at that point in time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start10 May 2022
- Primary completion3 Feb 2025
- Study completion3 Feb 2025
Why it stopped: Was not able not determine a meaningful bioimpedance measurement that could be correlated to bladder fullness over time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Susceptible to FallsStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Curbell Medical Products, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183633
- Sponsor's protocol ID
- HRP-503
- Status last verified
- Feb 2025
- First submitted
- 7 Dec 2021
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Association Between Human Bioimpedance Measurements and Clinical Urodynamic Procedures
- ClinicalTrials.gov ID
- NCT05183633
- Acronym / sponsor ID
- HRP-503
- Conditions
- Patients Susceptible to Falls
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Was not able not determine a meaningful bioimpedance measurement that could be correlated to bladder fullness over time.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Curbell Medical Products, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 May 2022 (actual)
- Primary completion
- 3 Feb 2025 (actual)
- Study completion
- 3 Feb 2025 (actual)
- First posted
- 10 Jan 2022 (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.
A Pilot Study to Assess the Association between Human Bioimpedance Measurements and Clinical Urodynamic Procedures
Detailed description
The purpose of the study is to assess how well Curbell's Bladder Sensor device measuring bioimpedance correlates to urodynamic studies and the reported sensation subjects feel when reporting bladder fullness and their urge to urinate.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One single trial | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients that have been previously scheduled for a urodynamic study
Key inclusion criteria (1 listed)
- Patients that have been previously scheduled for a Urodynamic Study
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation of Urge to Urinate to Bioimpedance. Our clinical trial is an attempt to determine the correlation of bioimpedance measurements versus bladder pressure (fullness) taken at the same time during a normally scheduled urodynamic study.
Time frame: Bioimpedance measurements are taken in real time simultaneously with urodynamic pressure measurements. Therefore, the time frame is "zero." Each measurement characterizes actual bioimpedance at that point in time.
Our primary outcome is determining the correlation strength between the bladder's pressure measurements (acquired during a standard urodynamic study) and bioimpedance measurements. That is, we are trying to find if bladder bioimpedance is correlated to bladder fullness, where pressure is the clinically-accepted measurement of bladder fullness in a urodynamic study.
Results and safety
The study was stopped early (reason given: Was not able not determine a meaningful bioimpedance measurement that could be correlated to bladder fullness over time.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Patients Susceptible to Falls, run by Curbell Medical Products, 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 6 Feb 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 was stopped early (reason given: Was not able not determine a meaningful bioimpedance measurement that could be correlated to bladder fullness over time.). Results are not available in the source record.
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?
Correlation of Urge to Urinate to Bioimpedance. Our clinical trial is an attempt to determine the correlation of bioimpedance measurements versus bladder pressure (fullness) taken at the same time during a normally scheduled urodynamic study. (time frame: Bioimpedance measurements are taken in real time simultaneously with urodynamic pressure measurements. Therefore, the time frame is "zero." Each measurement characterizes actual bioimpedance at that point in time.). 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 6 Feb 2025; AzTrials last refreshed its copy on 31 Oct 2026.