UTINCT05408533
Silver-Coated vs Standard Catheter for UTI Prevention
A study testing 2-Way Foley Urethral Urinary Catheter in people with UTI, run by TriHealth Inc. at 2 sites in United States.
Trial summary
Primary Aim: To determine whether silver-coated transurethral catheter decreases the incidence of culture-confirmed urinary tract infection for women with catheter-managed urinary retention after pelvic reconstructive surgery Secondary Aims: To assess difference in bacterial uropathogens isolated in urine cultures… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- UTI
- What is being tested?
- 2-Way Foley Urethral Urinary Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 310 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Jun 2022to 1 May 2024
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who undergo major or minor pelvic organ prolapse surgery of any compartment, or urinary incontinence surgery that are diagnosed with POUR via failed retrograde voiding trial and require an indwelling transurethral catheter upon hospital discharge. Sacral neuromodulation procedures and intradetrusor onabotulinumtoxinA (Botox) injections are excluded.
Who cannot join
- Unwilling or unable to participate in the study.
- Unwilling or unable to do a catheter self-removal at home.
- Inability to understand English.
- Pregnant women
- Patient personal history of urogenital anomaly, neurogenic bladder, use of chronic self-intermittent catheterization or suprapubic tubes, ureteral stents or other genitourinary indwelling devices, immunosuppressed state or chronic use of steroids.
- Currently (prior 3 months) undergoing medical management for recurrent UTI or interstitial cystitis
Show all 10Show fewer
- Active urinary tract infection.
- Intraoperative bladder injury or cystotomy
- Physical or mental impairment that would affect the subject's ability to perceive urinary tract infection symptoms
- Reported allergy to silver metal
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cincinnati Urogynecology Associates
Cincinnati, Ohio, 45220
Good Samaritan Hospital
Cincinnati, Ohio, 45220
About this study
Official title: Silver-coated Catheter Versus Standard Catheter for UTI Prevention in a Short-term Transurethral Indwelling Catheter Population After Pelvic Reconstructive Surgery: A Randomized Controlled Trial
Primary Aim: To determine whether silver-coated transurethral catheter decreases the incidence of culture-confirmed urinary tract infection for women with catheter-managed urinary retention after pelvic reconstructive surgery
Secondary Aims:
To assess difference in bacterial uropathogens isolated in urine cultures Adverse symptoms possibly caused by silver-coated catheter
- Conditions
- UTI
- Being tested
- 2-Way Foley Urethral Urinary Catheter
- Keywords
- Silver-coated catheter, UTI, Pelvic Reconstructive Surgery, Urogynecology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-Way Foley Urethral Urinary CatheterDevice
Comparing two types of catheter (silver-coated silicone versus silicone) after Pelvic Reconstructive Surgery (PRS) to compare Urinary Tract Infection (UTI) rates
| Study group | Role | What they receive |
|---|---|---|
| Silver-Coated Catheter | Active comparator | Not described Receives: Device: 2-Way Foley Urethral Urinary Catheter |
| Standard Catheter | Placebo comparator | Not described Receives: Device: 2-Way Foley Urethral Urinary Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of UTIs requiring treatment
Post-operative UTI rate
Measured: approximately 4 weeks
Secondary outcomes (2)
Assess the types of bacterial uropathogens isolated from the urine cultures
Measured: approximately 4 weeks
Adverse symptoms possibly causes by silver-coated catheter
Measured: approximately 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start14 Jun 2022
- Primary completion16 Feb 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UTIStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Yeung, DO, Principal investigator, TriHealth Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408533
- Sponsor's protocol ID
- 22-004
- Status last verified
- Nov 2024
- First submitted
- 29 Apr 2022
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lewis K, Crisp C, Ray M, Bonglack M, Carrel-Lammert M, Aldrich E, Pauls R, Hoehn J, Yeung J. Silver-Coated Foley Catheters to Reduce UTIs: A Randomized Clinical Trial. Urogynecology (Phila). 2025 Mar 1;31(3):276-284. doi: 10.1097/SPV.0000000000001634. Epub 2025 Jan 2.
PubMed 39744866
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Silver-coated Catheter Versus Standard Catheter for UTI Prevention in a Short-term Transurethral Indwelling Catheter Population After Pelvic Reconstructive Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05408533
- Acronym / sponsor ID
- 22-004
- Conditions
- UTI
- Keywords
- Silver-coated catheter, UTI, Pelvic Reconstructive Surgery, Urogynecology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 16 Feb 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 7 Jun 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.
Primary Aim: To determine whether silver-coated transurethral catheter decreases the incidence of culture-confirmed urinary tract infection for women with catheter-managed urinary retention after pelvic reconstructive surgery
Secondary Aims:
To assess difference in bacterial uropathogens isolated in urine cultures Adverse symptoms possibly caused by silver-coated catheter
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silver-Coated Catheter | Active comparator | Device: 2-Way Foley Urethral Urinary Catheter |
| Standard Catheter | Placebo comparator | Device: 2-Way Foley Urethral Urinary Catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who undergo major or minor pelvic organ prolapse surgery of any compartment, or urinary incontinence surgery that are diagnosed with POUR via failed retrograde voiding trial and require an indwelling transurethral catheter upon hospital discharge. Sacral neuromodulation procedures and intradetrusor onabotulinumtoxinA (Botox) injections are excluded.
Key exclusion criteria (10 listed)
- Unwilling or unable to participate in the study.
- Unwilling or unable to do a catheter self-removal at home.
- Inability to understand English.
- Pregnant women
- Patient personal history of urogenital anomaly, neurogenic bladder, use of chronic self-intermittent catheterization or suprapubic tubes, ureteral stents or other genitourinary indwelling devices, immunosuppressed state or chronic use of steroids.
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 |
|---|---|---|
| 2-Way Foley Urethral Urinary CatheterComparing two types of catheter (silver-coated silicone versus silicone) after Pelvic Reconstructive Surgery (PRS) to compare Urinary Tract Infection (UTI) rates | Device | Silver-Coated Catheter, Standard Catheter |
Primary outcome
Incidence of UTIs requiring treatment
Time frame: approximately 4 weeks
Post-operative UTI rate
2 secondary outcomes
Assess the types of bacterial uropathogens isolated from the urine cultures
Time frame: approximately 4 weeks
Adverse symptoms possibly causes by silver-coated catheter
Time frame: approximately 4 weeks
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 25 Nov 2024.
- Derived from this study: PubMed 39744866Lewis K, Crisp C, Ray M, Bonglack M, Carrel-Lammert M, Aldrich E, Pauls R, Hoehn J, Yeung J. Silver-Coated Foley Catheters to Reduce UTIs: A Randomized Clinical Trial. Urogynecology (Phila). 2025 Mar 1;31(3):276-284. doi: 10.1097/SPV.0000000000001634. Epub 2025 Jan 2.
- 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.
Jennifer Yeung, DO principal investigator
TriHealth Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2-Way Foley Urethral Urinary Catheter in people with UTI, run by TriHealth Inc. at 2 sites 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 10 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 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 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?
Incidence of UTIs requiring treatment (time frame: approximately 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05408533, which also lists 1 linked publication.
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 25 Nov 2024.