Quality of LifePhase 4NCT02266368
Comparison of Antimicrobial Coated Ureteral Stents With Non-coated Stents
A Phase 4 study testing Antimicrobeal coated stents in people with Quality of Life, run by Mansoura University at 1 site in Egypt.
Trial summary
This study will be conducted to compare the efficacy of antimicrobial coated ureteral stent with non-coated stents in prevention of UTI in patients with ureteral stents Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Quality of Life
- What is being tested?
- Antimicrobeal coated stents
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2014to Sep 2016
- Phase
- Phase 4
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who will undergo ureteral stent placement
Who cannot join
- Patients allergic to sulpha containing medications
- Ureteral stent insertion for infected hydronephrosis
- Patients who developed septic complications requiring antibiotic treatment after stent placement
- Patients who need bilateral stents
- Patients with chronic kidney disease grade IV and V (GFR <30ml/min)
- Immunocompromised patients as those with malignancy or organ transplantation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Comparing Antimicrobial Coated (Silver Sulfadiazine) Ureteral Stents With Non-coated Stents
This study will be conducted to compare the efficacy of antimicrobial coated ureteral stent with non-coated stents in prevention of UTI in patients with ureteral stents
Read the detailed description
The efficacy of antimicrobial coated of ureteral stent with silver sulphadiazine in prevention of UTI in patients with ureteral stents will be studied by comparining the results of urine and stent cultures with patients who had non-coated ureteral stents. The impact of antimicrobeal stent coating on patients' quality of life will be evaluated with comparing the scores of ureteral stent symptom questionnaire between both groups.
- Conditions
- Quality of Life
- Being tested
- Antimicrobeal coated stents
- Keywords
- Ureteral stents, Double J stent, Antimicoreal coated stent, USSQ, UTI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antimicrobeal coated stentsDevice
Patients in the intervention arm will undergo placement of (Silver Sulphdiazine) antimicrobeal coated stents
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | This arm will include patients with non-coated stents |
| Antimicrobeal group | Active comparator | This arm will include patients with antimicrobeal coated stents Receives: Device: Antimicrobeal coated stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of urinary tract infection (UTI)
UTI will be diagnosed with urine and stent culture of stent removal
Measured: up to 3 months
Secondary outcomes (1)
Quality of life
The impact of stent coating on quality of life will be assissed with ureteral stent symptom questionnaire (USSQ)
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed R. EL-Nahas, Mansoura University
- Investigators
- Ahmed R EL-NAHAS, MD, Study director, Assistant Professour, urology department, urology and nephrology center, mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266368
- Sponsor's protocol ID
- Antimicrobeal ureteral stents
- Status last verified
- Sep 2016
- First submitted
- 11 Oct 2014
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Antimicrobial Coated (Silver Sulfadiazine) Ureteral Stents With Non-coated Stents
- ClinicalTrials.gov ID
- NCT02266368
- Acronym / sponsor ID
- Antimicrobeal ureteral stents
- Conditions
- Quality of Life
- Keywords
- Ureteral stents, Double J stent, Antimicoreal coated stent, USSQ, UTI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 17 Oct 2014 (estimated)
- 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.
This study will be conducted to compare the efficacy of antimicrobial coated ureteral stent with non-coated stents in prevention of UTI in patients with ureteral stents
Detailed description
The efficacy of antimicrobial coated of ureteral stent with silver sulphadiazine in prevention of UTI in patients with ureteral stents will be studied by comparining the results of urine and stent cultures with patients who had non-coated ureteral stents. The impact of antimicrobeal stent coating on patients' quality of life will be evaluated with comparing the scores of ureteral stent symptom questionnaire between both groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –This arm will include patients with non-coated stents |
| Antimicrobeal group | Active comparator | Device: Antimicrobeal coated stentsThis arm will include patients with antimicrobeal coated stents |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients who will undergo ureteral stent placement
Key exclusion criteria (6 listed)
- Patients allergic to sulpha containing medications
- Ureteral stent insertion for infected hydronephrosis
- Patients who developed septic complications requiring antibiotic treatment after stent placement
- Patients who need bilateral stents
- Patients with chronic kidney disease grade IV and V (GFR <30ml/min)
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 |
|---|---|---|
| Antimicrobeal coated stentsPatients in the intervention arm will undergo placement of (Silver Sulphdiazine) antimicrobeal coated stents | Device | Antimicrobeal group |
Primary outcome
Incidence of urinary tract infection (UTI)
Time frame: up to 3 months
UTI will be diagnosed with urine and stent culture of stent removal
1 secondary outcome
Quality of life
Time frame: up to 3 months
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 13 Sep 2016.
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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.
Ahmed R EL-NAHAS, MD study director
Assistant Professour, urology department, urology and nephrology center, mansoura university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antimicrobeal coated stents in people with Quality of Life, run by Mansoura University at 1 site in Egypt.
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 6 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 13 Sep 2016. 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 urinary tract infection (UTI) (time frame: up to 3 months). 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 13 Sep 2016.