Urinary StonesNCT02211313
Evaluation of Ureteral Stents in the Management of Stone Disease
A study testing Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent. in people with Urinary Stones and Urinary Tract Stones, run by Washington University School of Medicine at 1 site in United States.
Trial summary
A thin tube, called a ureteral stent, is inserted into the ureter and is commonly used as treatment of urinary stone disease. Stents are designed to help provide drainage of the kidney in the setting of an obstructing stone, or postoperative swelling of the ureter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Stones, Urinary Tract Stones
- What is being tested?
- Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to 3 Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Over 18 years of age and willing and able to provide informed consent
- Patients with current urinary stone disease, undergoing any of the following procedures:
- cystoscopy with stent placement
- ureteroscopy with intracorporeal lithotripsy
Who cannot join
- Patients with compromised urinary tract due to cancer (e.g. bladder tumor, ureteral obstruction from non-GU malignancy)
- Patients requiring bilateral surgical stone management procedure
- Patients with any single stone exceeding 1.5 cm
- Patients with severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would render the patient inappropriate for enrollment
- Any patient who is on anticholinergic medication at baseline
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
A thin tube, called a ureteral stent, is inserted into the ureter and is commonly used as treatment of urinary stone disease. Stents are designed to help provide drainage of the kidney in the setting of an obstructing stone, or postoperative swelling of the ureter. Though their presence is only temporary, stents are associated with a significant amount of patient discomfort and bother, which can negatively impact overall satisfaction. Over the past decades, there have been refinements in stent technology and usage philosophy. Smaller and softer stents are now available for use in patients, though studies evaluating the relative benefits have been conflicting. The investigators aim to evaluate the effect of stent size and composition upon outcomes after the treatment of stone disease, including patient comfort and satisfaction.
- Conditions
- Urinary Stones, Urinary Tract Stones
- Being tested
- Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.
- Medical subject headings
- Urinary Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.Device
Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1.
| Study group | Role | What they receive |
|---|---|---|
| Ureteral stent - soft, 6 French | Active comparator | Subjects randomized to soft stent, size 6 French Receives: Device: Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent. |
| Ureteral stent - hydrophobic, 6 French | Active comparator | Subjects randomized to hydrophobic stent, size 6 French Receives: Device: Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Pain on the 10-point Analog Pain Scale at Day 7 Post Stent Removal.
The 10-point scale ranges from 0 (zero) for no pain (minimum) to 10 for the worst possible pain (maximum). The unit of measure is 1 point on the 10-point scale.
Measured: Baseline, day 7 post stent removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startAug 2014
- Primary completion3 Apr 2018
- Study completion3 Apr 2018
Why it stopped: Lack of further funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary StonesStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alana C Desai, M.D., Principal investigator, Washington UniversitySchool of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211313
- Sponsor's protocol ID
- 201205184
- Status last verified
- May 2019
- First submitted
- 4 Aug 2014
- Last updated
- 5 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ureteral Stents in the Management of Stone Disease
- ClinicalTrials.gov ID
- NCT02211313
- Acronym / sponsor ID
- 201205184
- Conditions
- Urinary Stones, Urinary Tract Stones
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of further funding.
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- 3 Apr 2018 (actual)
- Study completion
- 3 Apr 2018 (actual)
- First posted
- 7 Aug 2014 (estimated)
- Results
- Posted 21 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A thin tube, called a ureteral stent, is inserted into the ureter and is commonly used as treatment of urinary stone disease. Stents are designed to help provide drainage of the kidney in the setting of an obstructing stone, or postoperative swelling of the ureter. Though their presence is only temporary, stents are associated with a significant amount of patient discomfort and bother, which can negatively impact overall satisfaction. Over the past decades, there have been refinements in stent technology and usage philosophy. Smaller and softer stents are now available for use in patients, though studies evaluating the relative benefits have been conflicting. The investigators aim to evaluate the effect of stent size and composition upon outcomes after the treatment of stone disease, including patient comfort and satisfaction.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ureteral stent - soft, 6 French | Active comparator | Device: Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.Subjects randomized to soft stent, size 6 French |
| Ureteral stent - hydrophobic, 6 French | Active comparator | Device: Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.Subjects randomized to hydrophobic stent, size 6 French |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years of age and willing and able to provide informed consent
- Patients with current urinary stone disease, undergoing any of the following procedures:
Key exclusion criteria (5 listed)
- Patients with compromised urinary tract due to cancer (e.g. bladder tumor, ureteral obstruction from non-GU malignancy)
- Patients requiring bilateral surgical stone management procedure
- Patients with any single stone exceeding 1.5 cm
- Patients with severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would render the patient inappropriate for enrollment
- Any patient who is on anticholinergic medication at baseline
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 |
|---|---|---|
| Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1. | Device | Ureteral stent - hydrophobic, 6 French, Ureteral stent - soft, 6 French |
Primary outcome
Change From Baseline in Pain on the 10-point Analog Pain Scale at Day 7 Post Stent Removal.
Time frame: Baseline, day 7 post stent removal
The 10-point scale ranges from 0 (zero) for no pain (minimum) to 10 for the worst possible pain (maximum). The unit of measure is 1 point on the 10-point scale.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Alana C Desai, M.D. principal investigator
Washington UniversitySchool of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent. in people with Urinary Stones and Urinary Tract Stones, run by Washington University School of Medicine 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 5 Jun 2019. 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?
Yes. Results are posted in the registry (first posted 21 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Pain on the 10-point Analog Pain Scale at Day 7 Post Stent Removal. (time frame: Baseline, day 7 post stent removal). 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 5 Jun 2019; AzTrials last refreshed its copy on 8 Nov 2026.