Catheter-Related InfectionsNCT03178734
Foley Catheter vs a Self-contained Valved Urinary Catheter
A study testing Foley Catheter vs Self-Contained Valved Catheter in people with Catheter-Related Infections and Urinary Tract Infections, run by charbel salamon at 1 site in United States.
Trial summary
The purpose of this study is to compare UTI rates and patient satisfaction associated with indwelling Foley catheter verses a valved catheter in patients who are being discharged home with a catheter after urogynecologic procedures via a Randomized Clinical Trial. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Catheter-Related Infections, Urinary Tract Infections, Urogynecologic Surgery
- What is being tested?
- Foley Catheter vs Self-Contained Valved Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2016to 30 Jun 2019
- 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
- All patients undergoing pelvic reconstructive surgery/anti-incontinence procedures who are planned to be discharged home with a catheter.
Who cannot join
- Intra-operative bladder injury during index surgery
- Intra-operative complication requiring continuous bladder drainage
- Dementia / altered cognitive function
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlantic Urogynecology Associates
Morristown, New Jersey, 07960
About this study
Official title: Foley Catheter vs a Self-contained Valved Urinary Catheter for Patients Who Are Being Discharged Home With a Catheter After Urogynecologic Procedures
The purpose of this study is to compare UTI rates and patient satisfaction associated with indwelling Foley catheter verses a valved catheter in patients who are being discharged home with a catheter after urogynecologic procedures via a Randomized Clinical Trial.
Read the detailed description
The purpose of this study is to compare UTI rates and patient satisfaction associated with indwelling Foley catheter verses a valved catheter in patients who are being discharged home with a catheter after urogynecologic procedures via a Randomized Clinical Trial. Total number of participants will be 100. Inclusion criteria is all patients undergoing pelvic reconstructive surgery/anti-incontinence procedures who are planned to be discharged home with a catheter. Exclusion criteria is intra-operative bladder injury during index surgery; intra-operative complication requiring continuous bladder drainage; and/or dementia/altered cognitive function.
- Being tested
- Foley Catheter vs Self-Contained Valved Catheter
- Medical subject headings
- Catheter-Related Infections, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foley Catheter vs Self-Contained Valved CatheterDevice
This study aims to compare UTI rates and patient satisfaction between an indwelling Foley catheter group (established SOC); and a relatively (FDA-approved) new valved addition to the Foley catheter which requires no drainage bag.
| Study group | Role | What they receive |
|---|---|---|
| Indwelling Foley Catheter | Other | These patients will have a traditional foley catheter with attached drainage bag (Indwelling Foley Catheter). Receives: Device: Foley Catheter vs Self-Contained Valved Catheter |
| Self-Contained Valved Catheter | Other | These patients will have a BARD Flip Flo Catheter Valve attached to the original foley catheter (Self-Contained Valved Catheter). Receives: Device: Foley Catheter vs Self-Contained Valved Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of urinary tract infections
Number of urine cultures positive for infection (taken at voiding trial visit and post-operative visit).
Measured: Up to 4 weeks after surgery
Secondary outcomes (2)
Patient satisfaction
Foley satisfaction questionnaire will be collected at post-operative voiding trial office visit.
Measured: Up to 5 days after surgery
Number of days until spontaneous void/Number of calls for device-related issues
Number of days until spontaneous void and number of call for device-related issues.
Measured: Up to 4 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start22 Jul 2016
- Primary completion14 Jun 2019
- Study completion30 Jun 2019
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 Catheter-Related InfectionsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study aim is to compare UTI rates and patient satisfaction associated with indwelling Foley catheter vs a valved catheter in patients who are being discharged home with a catheter after urogynecologic proecures via a Randomized Clinical Trial.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- charbel salamon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, charbel salamon, Atlantic Health System
- Investigators
- Charbel G Salamon, MD, MS, Principal investigator, Atlantic Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178734
- Sponsor's protocol ID
- 908398
- Status last verified
- Jul 2020
- First submitted
- 11 May 2017
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.
PubMed 34184246
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foley Catheter vs a Self-contained Valved Urinary Catheter for Patients Who Are Being Discharged Home With a Catheter After Urogynecologic Procedures
- ClinicalTrials.gov ID
- NCT03178734
- Acronym / sponsor ID
- 908398
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- charbel salamonUniversity, hospital or other
- Study start
- 22 Jul 2016 (actual)
- Primary completion
- 14 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 7 Jun 2017 (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 purpose of this study is to compare UTI rates and patient satisfaction associated with indwelling Foley catheter verses a valved catheter in patients who are being discharged home with a catheter after urogynecologic procedures via a Randomized Clinical Trial.
Detailed description
The purpose of this study is to compare UTI rates and patient satisfaction associated with indwelling Foley catheter verses a valved catheter in patients who are being discharged home with a catheter after urogynecologic procedures via a Randomized Clinical Trial. Total number of participants will be 100. Inclusion criteria is all patients undergoing pelvic reconstructive surgery/anti-incontinence procedures who are planned to be discharged home with a catheter. Exclusion criteria is intra-operative bladder injury during index surgery; intra-operative complication requiring continuous bladder drainage; and/or dementia/altered cognitive function.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study aim is to compare UTI rates and patient satisfaction associated with indwelling Foley catheter vs a valved catheter in patients who are being discharged home with a catheter after urogynecologic proecures via a Randomized Clinical Trial.
| Arm | Type | Receives |
|---|---|---|
| Indwelling Foley Catheter | Other | Device: Foley Catheter vs Self-Contained Valved CatheterThese patients will have a traditional foley catheter with attached drainage bag (Indwelling Foley Catheter). |
| Self-Contained Valved Catheter | Other | Device: Foley Catheter vs Self-Contained Valved CatheterThese patients will have a BARD Flip Flo Catheter Valve attached to the original foley catheter (Self-Contained Valved 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)
- All patients undergoing pelvic reconstructive surgery/anti-incontinence procedures who are planned to be discharged home with a catheter.
Key exclusion criteria (3 listed)
- Intra-operative bladder injury during index surgery
- Intra-operative complication requiring continuous bladder drainage
- Dementia / altered cognitive function
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 |
|---|---|---|
| Foley Catheter vs Self-Contained Valved CatheterThis study aims to compare UTI rates and patient satisfaction between an indwelling Foley catheter group (established SOC); and a relatively (FDA-approved) new valved addition to the Foley catheter which requires no drainage bag. | Device | Indwelling Foley Catheter, Self-Contained Valved Catheter |
Primary outcome
Number of urinary tract infections
Time frame: Up to 4 weeks after surgery
Number of urine cultures positive for infection (taken at voiding trial visit and post-operative visit).
2 secondary outcomes
Patient satisfaction
Time frame: Up to 5 days after surgery
Number of days until spontaneous void/Number of calls for device-related issues
Time frame: Up to 4 weeks after surgery
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 28 Jul 2020.
- Derived from this study: PubMed 34184246Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.
- 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.
Charbel G Salamon, MD, MS principal investigator
Atlantic Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foley Catheter vs Self-Contained Valved Catheter in people with Catheter-Related Infections and Urinary Tract Infections, run by charbel salamon 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 3 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 28 Jul 2020. 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?
Number of urinary tract infections (time frame: Up to 4 weeks after surgery). 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 NCT03178734, 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 28 Jul 2020; AzTrials last refreshed its copy on 31 Oct 2026.