Neurogenic BladderNCT03785262
Low Energy Surface Waves for Neurogenic Bladder Patients With Indwelling Catheters
A study testing Uroshield in people with Neurogenic Bladder and Urinary Tract Infections, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
The Uroshield device is a commercially available device with two parts: a disposable actuator which attaches to the external portion of the catheter and a portable battery. The device sends out low-frequency ultrasound waves which run along the surfaces of the catheter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurogenic Bladder, Urinary Tract Infections
- What is being tested?
- Uroshield
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jan 2019to 30 Dec 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years of age
- Spinal cord injury (>1 year), multiple sclerosis (>1 year), spina bifida, parkinsons (>1 year)
- Indwelling catheter (urethral or suprapubic) for >3 months, and used as primary bladder management mechanism
- >1 urinary tract infection in the last 12 months
Who cannot join
- Intravesical botox in the last 6 months
- Chronic antibiotic suppressive therapy
- Active symptomatic UTI on day of randomization
- Unable to understand written and spoken English
- Prior/current utilization of the Uroshield device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Energy Surface Waves to Prevent Urinary Infections and Catheter Associated Symptoms Among Patients With Neurogenic Bladder Dysfunction
The Uroshield device is a commercially available device with two parts: a disposable actuator which attaches to the external portion of the catheter and a portable battery. The device sends out low-frequency ultrasound waves which run along the surfaces of the catheter. These acoustic waves prevent bacteria from adhering to the catheter and prevent the formation of biofilm. Our objective is to conduct a pilot study to determine if the UroShield device can reduce bacteriuria and catheter biofilm formation among neurogenic bladder patients with an indwelling catheter, as well as improve urinary quality of life and symptoms.
- Conditions
- Neurogenic Bladder, Urinary Tract Infections
- Being tested
- Uroshield, Sham Uroshield
- Medical subject headings
- Urinary Bladder, Neurogenic, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UroshieldDevice
The Uroshield device sends out low-frequency ultrasound waves which run along the surface of the catheter.
Sham UroshieldDevice
The sham Uroshield device is identical to the active machine, but it does not send out low-frequency ultrasound waves along the surface of the catheter.
| Study group | Role | What they receive |
|---|---|---|
| Sham | Sham comparator | Inactive uroshield device Receives: Device: Sham Uroshield |
| Active Uroshield | Experimental | Active uroshield device Receives: Device: Uroshield |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacteriuria
Proportion with bacteriuria >10^5 cfu at day 30
Measured: 30 days
Secondary outcomes (5)
Neurogenic bladder symptom score (NBSS)
Validated symptom score that measures symptoms related to neurogenic bladder dysfunction and urinary quality of life. Total scale ranges from 0-74, and a lower number is considered a better outcome and represents lower symptom burden.
Measured: 30 days
Patient subjective rating of amount of sediment/debris at the end of the 30 days
Measured: 30 days
Total bacterial cell counts
Measured: 30 days
Microbiome comparison of biofilms
Measured: 30 days
Scanning electron microscopy of biofilms
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start30 Jan 2019
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Why it stopped: Failure to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic BladderStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785262
- Sponsor's protocol ID
- 113221
- Status last verified
- Jan 2024
- First submitted
- 20 Dec 2018
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Energy Surface Waves to Prevent Urinary Infections and Catheter Associated Symptoms Among Patients With Neurogenic Bladder Dysfunction
- ClinicalTrials.gov ID
- NCT03785262
- Acronym / sponsor ID
- 113221
- Conditions
- Neurogenic Bladder, Urinary Tract Infections
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure to recruit
- Enrolment
- 6 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 24 Dec 2018 (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 Uroshield device is a commercially available device with two parts: a disposable actuator which attaches to the external portion of the catheter and a portable battery. The device sends out low-frequency ultrasound waves which run along the surfaces of the catheter. These acoustic waves prevent bacteria from adhering to the catheter and prevent the formation of biofilm. Our objective is to conduct a pilot study to determine if the UroShield device can reduce bacteriuria and catheter biofilm formation among neurogenic bladder patients with an indwelling catheter, as well as improve urinary quality of life and symptoms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham | Sham comparator | Device: Sham UroshieldInactive uroshield device |
| Active Uroshield | Experimental | Device: UroshieldActive uroshield device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >18 years of age
- Spinal cord injury (>1 year), multiple sclerosis (>1 year), spina bifida, parkinsons (>1 year)
- Indwelling catheter (urethral or suprapubic) for >3 months, and used as primary bladder management mechanism
- >1 urinary tract infection in the last 12 months
Key exclusion criteria (5 listed)
- Intravesical botox in the last 6 months
- Chronic antibiotic suppressive therapy
- Active symptomatic UTI on day of randomization
- Unable to understand written and spoken English
- Prior/current utilization of the Uroshield device
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 |
|---|---|---|
| UroshieldThe Uroshield device sends out low-frequency ultrasound waves which run along the surface of the catheter. | Device | Active Uroshield |
| Sham UroshieldThe sham Uroshield device is identical to the active machine, but it does not send out low-frequency ultrasound waves along the surface of the catheter. | Device | Sham |
Primary outcome
Bacteriuria
Time frame: 30 days
Proportion with bacteriuria >10^5 cfu at day 30
5 secondary outcomes
Neurogenic bladder symptom score (NBSS)
Time frame: 30 days
Patient subjective rating of amount of sediment/debris at the end of the 30 days
Time frame: 30 days
Total bacterial cell counts
Time frame: 30 days
Microbiome comparison of biofilms
Time frame: 30 days
Scanning electron microscopy of biofilms
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Failure to recruit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Individual participant dataSharing planned: No. No plan
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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.
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?
A study testing Uroshield in people with Neurogenic Bladder and Urinary Tract Infections, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 4 inclusion and 5 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 12 Jan 2024. 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 Canada. 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. Some participants in this study may receive a placebo. 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: Failure to recruit). 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?
Bacteriuria (time frame: 30 days). 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 12 Jan 2024.