Quality of Life in Patients With Double Loop Ureteral Stent (JJ Silicone Hydrogel Study)

July 1, 2015 updated by: Coloplast A/S

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75020
        • Recruiting
        • Service de Chirurgie Urologique de l'Hôpital Tenon
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male and female patients
  2. Aged > 18 years
  3. 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)
  4. Index stone of 5-25 mm (measured on plain abdomen X-Ray KUB or CT)
  5. Without any currently implanted JJ stent
  6. Patient agreed to participate to the study and having signed the consent form
  7. Able to complete self-rated questionnaires.

Exclusion Criteria:

  1. Acute ureteric/nephritic colic (residual pain is acceptable)
  2. Any type of chronic pain
  3. Large stones > 25 mm
  4. Infection renal stone already diagnosed and documented
  5. Malformation of urinary tract (e.g. Horseshoe kidney, duplicity or, ureterocele, mega ureter)
  6. Diverticulum stone
  7. Urogenital tumor
  8. Any significant neurological disease or injury impacting sensation
  9. JJ stents already implanted
  10. Patients with long-term indwelling urethral catheter
  11. No indication for JJ insertion (e.g. spontaneous stone passage)
  12. Untreated urinary tract infection
  13. Ureteral obstruction (stenosis, compression, calculi)
  14. Neurogenic bladder
  15. Overactive bladder
  16. Bladder stone
  17. Chronic prostatitis
  18. BPH treated (recent initiation of 5 alpha-Reductase Inhibitor or Phytotherapeutic agents)
  19. Ongoing Alpha-Blocker or Anticholinergic medication
  20. Pregnancy
  21. Any event discovered during the endoscopy which is not compatible with the study design and objective

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Coloplast Hydrocoated silicone JJ stent
Double loop ureteral stent endoscopic placement
Device: 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
Active Comparator: Boston Percuflex Plus JJ stent
Double loop ureteral stent endoscopic placement
Device: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
USSQ scale (Ureteral Stent Symptoms Questionnaire)
Time Frame: at day 20
at day 20

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
Day 2, 7 and 35

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Encrustation of double loop ureteral stents
Time Frame: after 20 days (JJ stent removal)
Encrustation of double loop ureteral stents is evaluated by a score of integer values ranging from 0 to 6
after 20 days (JJ stent removal)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Coloplast A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Olivier PJ Traxer, Professor, Service de Chirurgie Urologique de l'Hôpital Tenon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 3, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DUDLUIV1201EC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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