Kidney CalculiPhase 4NCT02489656
Quality of Life in Patients With Double Loop Ureteral Stent (JJ Silicone Hydrogel Study)
A Phase 4 study testing Double Loop Ureteral stent endoscopic placement. in people with Kidney Calculi, run by Coloplast A/S at 1 site in France.
Trial summary
This study is a prospective, randomized multicenter study conducted in Europe. It is designed to compare two double loop ureteral stents in terms of the quality of life in patients operated on a kidney stone and requiring the placement of a double loop ureteral stent at the end of the operation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Calculi
- What is being tested?
- Double Loop Ureteral stent endoscopic placement.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2013to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients
- Aged > 18 years
- Unilateral renal non-infection stone for whom the treatment indication is a flexible ureterorenoscopy (multiple kidney stones are acceptable provided that only one side is currently symptomatic)
- Index stone of 5-25 mm (measured on plain abdomen X-Ray KUB or CT)
- Without any currently implanted JJ stent
- Patient agreed to participate to the study and having signed the consent form
- Able to complete self-rated questionnaires.
Who cannot join
- Acute ureteric/nephritic colic (residual pain is acceptable)
- Any type of chronic pain
- Large stones > 25 mm
- Infection renal stone already diagnosed and documented
- Malformation of urinary tract (e.g. Horseshoe kidney, duplicity or, ureterocele, mega ureter)
- Diverticulum stone
Show all 21Show fewer
- Urogenital tumor
- Any significant neurological disease or injury impacting sensation
- JJ stents already implanted
- Patients with long-term indwelling urethral catheter
- No indication for JJ insertion (e.g. spontaneous stone passage)
- Untreated urinary tract infection
- Ureteral obstruction (stenosis, compression, calculi)
- Neurogenic bladder
- Overactive bladder
- Bladder stone
- Chronic prostatitis
- BPH treated (recent initiation of 5 alpha-Reductase Inhibitor or Phytotherapeutic agents)
- Ongoing Alpha-Blocker or Anticholinergic medication
- Pregnancy
- Any event discovered during the endoscopy which is not compatible with the study design and objective
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Chirurgie Urologique de l'Hôpital Tenon
Paris, 75020
Olivier PJ Traxer, Professor, 33 1 56 01 61 53., olivier.traxer@tnn.aphp.fr
About this study
Official title: Effect of a Silicone Hydrocoated Double Loop Ureteral Stent on Symptoms and Quality of Life in Patients Undergoing F-URS for Kidney Stone; a Comparative Randomized Multicenter Clinical Study.
This study is a prospective, randomized multicenter study conducted in Europe. It is designed to compare two double loop ureteral stents in terms of the quality of life in patients operated on a kidney stone and requiring the placement of a double loop ureteral stent at the end of the operation.
Read the detailed description
- The double loop stents are used for both prevention and treatment of ureteral obstruction: They permit the interim internal bypass drainage of urine when obstruction in the ureter especially in cases of lithiasis or after surgical intervention on the upper urinary tract.
- There are many indications for double loop stent placement and population chosen for this study are adult patients with intra-renal calcium calculi of 7-20 mm in diameter for whom the treatment indication is a flexible ureterorenoscopy.
- The aims of the use of a double loop stent are to
- prevent complications (pain, infection) associated with the ureteral obstruction by any residual stone fragments, blood clot or local oedema generated by the intervention.
- preserve the renal function.
- facilitate healing process while limiting the risk of stenosis and probably reduce the rate of readmission after patients' discharge.
- Double loop Stent-related symptoms have a high prevalence and may affect over 80% of patients.
- Assessment tools are important to determine the symptoms intensity and allow for comparisons at different times. The Urinary Stent Symptom Questionnaire (USSQ) is the most adapted tool designed for this purpose.
- An ideal ureteral stent is expected to drain well, to be easy to insert and to be comfortable for the patients. The investigators designed a hydro-coated Silicone JJ stent with additional properties for improving patient's comfort.
- The investigators decided to perform a randomized clinical investigation to evaluate the Coloplast Hydrocoated Silicone JJ in comparison to the Boston Percuflex Plus JJ stent on patients' comfort.
- Conditions
- Kidney Calculi
- Being tested
- Double Loop Ureteral stent endoscopic placement.
- Keywords
- Double loop ureteral stent, USSQ, Quality of life, Pain
- Medical subject headings
- Kidney Calculi, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double Loop Ureteral stent endoscopic placement.Device
A JJ stent placement may be indicated at the end of the endourological removal of kidney stones to ensure urine drainage and cicatrisation
| Study group | Role | What they receive |
|---|---|---|
| Coloplast Hydrocoated silicone JJ stent | Experimental | Double loop ureteral stent endoscopic placement Receives: Device: Double Loop Ureteral stent endoscopic placement. |
| Boston Percuflex Plus JJ stent | Active comparator | Double loop ureteral stent endoscopic placement Receives: Device: Double Loop Ureteral stent endoscopic placement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
USSQ scale (Ureteral Stent Symptoms Questionnaire)
Measured: at day 20
Secondary outcomes (1)
Evaluate impact on quality of life via the USSQ questionnaire assessing 5 other scores and adverse event reporting at all visits.
Measured: Day 2, 7 and 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startSep 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CalculiStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Olivier PJ Traxer, Professor, Principal investigator, Service de Chirurgie Urologique de l'Hôpital Tenon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489656
- Sponsor's protocol ID
- DUDLUIV1201EC
- Status last verified
- May 2015
- First submitted
- 18 May 2015
- Last updated
- 3 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Silicone Hydrocoated Double Loop Ureteral Stent on Symptoms and Quality of Life in Patients Undergoing F-URS for Kidney Stone; a Comparative Randomized Multicenter Clinical Study.
- ClinicalTrials.gov ID
- NCT02489656
- Acronym / sponsor ID
- DUDLUIV1201EC
- Conditions
- Kidney Calculi
- Keywords
- Double loop ureteral stent, USSQ, Quality of life, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 3 Jul 2015 (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 is a prospective, randomized multicenter study conducted in Europe. It is designed to compare two double loop ureteral stents in terms of the quality of life in patients operated on a kidney stone and requiring the placement of a double loop ureteral stent at the end of the operation.
Detailed description
- The double loop stents are used for both prevention and treatment of ureteral obstruction: They permit the interim internal bypass drainage of urine when obstruction in the ureter especially in cases of lithiasis or after surgical intervention on the upper urinary tract.
- There are many indications for double loop stent placement and population chosen for this study are adult patients with intra-renal calcium calculi of 7-20 mm in diameter for whom the treatment indication is a flexible ureterorenoscopy.
- The aims of the use of a double loop stent are to
- prevent complications (pain, infection) associated with the ureteral obstruction by any residual stone fragments, blood clot or local oedema generated by the intervention.
- preserve the renal function.
- facilitate healing process while limiting the risk of stenosis and probably reduce the rate of readmission after patients' discharge.
- Double loop Stent-related symptoms have a high prevalence and may affect over 80% of patients.
- Assessment tools are important to determine the symptoms intensity and allow for comparisons at different times. The Urinary Stent Symptom Questionnaire (USSQ) is the most adapted tool designed for this purpose.
- An ideal ureteral stent is expected to drain well, to be easy to insert and to be comfortable for the patients. The investigators designed a hydro-coated Silicone JJ stent with additional properties for improving patient's comfort.
- The investigators decided to perform a randomized clinical investigation to evaluate the Coloplast Hydrocoated Silicone JJ in comparison to the Boston Percuflex Plus JJ stent on patients' comfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coloplast Hydrocoated silicone JJ stent | Experimental | Device: Double Loop Ureteral stent endoscopic placement.Double loop ureteral stent endoscopic placement |
| Boston Percuflex Plus JJ stent | Active comparator | Device: Double Loop Ureteral stent endoscopic placement.Double loop ureteral stent endoscopic placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female patients
- Aged > 18 years
- Unilateral renal non-infection stone for whom the treatment indication is a flexible ureterorenoscopy (multiple kidney stones are acceptable provided that only one side is currently symptomatic)
- Index stone of 5-25 mm (measured on plain abdomen X-Ray KUB or CT)
- Without any currently implanted JJ stent
Key exclusion criteria (21 listed)
- Acute ureteric/nephritic colic (residual pain is acceptable)
- Any type of chronic pain
- Large stones > 25 mm
- Infection renal stone already diagnosed and documented
- Malformation of urinary tract (e.g. Horseshoe kidney, duplicity or, ureterocele, mega ureter)
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 |
|---|---|---|
| Double Loop Ureteral stent endoscopic placement.A JJ stent placement may be indicated at the end of the endourological removal of kidney stones to ensure urine drainage and cicatrisation | Device | Boston Percuflex Plus JJ stent, Coloplast Hydrocoated silicone JJ stent |
Primary outcome
USSQ scale (Ureteral Stent Symptoms Questionnaire)
Time frame: at day 20
1 secondary outcome
Evaluate impact on quality of life via the USSQ questionnaire assessing 5 other scores and adverse event reporting at all visits.
Time frame: Day 2, 7 and 35
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2015.
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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.
Olivier PJ Traxer, Professor principal investigator
Service de Chirurgie Urologique de l'Hôpital Tenon
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 Double Loop Ureteral stent endoscopic placement. in people with Kidney Calculi, run by Coloplast A/S at 1 site in France.
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 7 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 3 Jul 2015. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pascale HS Holliday, CTM (+33 1 40 83 68 58, frpho@coloplast.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
USSQ scale (Ureteral Stent Symptoms Questionnaire) (time frame: at day 20). 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 3 Jul 2015.