Ureter StoneNCT04145063
Ureteric Stenting Versus Non-stenting Following Uncomplicated Ureteroscopic Lithotripsy
A study testing no stent in people with Ureter Stone, run by University of Jordan at 1 site in Jordan.
Trial summary
This study aims to compare three groups of patients who underwent uncomplicated ureteroscopic lithotripsy (URSL) to evaluate whether stents could be eliminated after the procedure Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ureter Stone
- What is being tested?
- no stent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJordan
- Study dates
- 2 Feb 2016to 1 Dec 2020
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- unilateral ureteric stones managed by ureteroscopy
Who cannot join
- Stone size < 2 cm
- bilateral ureteral stones
- incomplete stone removal due to impacted stones
- failed ureteroscopic access to the stone
- stone migration to the kidney
- pregnancy
Show all 12Show fewer
- active urinary tract infection
- solitary kidney
- ureteral stent placed preoperatively
- severe mucosal injury or perforation
- suspected additional ureteral pathology such as ureteral stricture
- urothelial carcinoma or polyp.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ureteric Stenting Versus Non-stenting Following Uncomplicated Ureteroscopic Lithotripsy: A Prospective Randomized Trial
This study aims to compare three groups of patients who underwent uncomplicated ureteroscopic lithotripsy (URSL) to evaluate whether stents could be eliminated after the procedure
- Conditions
- Ureter Stone
- Being tested
- no stent
- Medical subject headings
- Ureterolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no stentOther
following uretroscopy, no stent will be placed
| Study group | Role | What they receive |
|---|---|---|
| uncomplicated ureteroscopic lithotripsy with DJ-US | No intervention | Following uncomplicated uretroscopic lithotripsy, a double J uretric stent will be placed (usually the standard of care) |
| uncomplicated ureteroscopic lithotripsy without US | Active comparator | Following uncomplicated uretroscopic lithotripsy no uretric stent will be placed Receives: Other: no stent |
| uncomplicated ureteroscopic lithotripsy with DJ-US-string | No intervention | Following uncomplicated uretroscopic lithotripsy, a double J uretric stent with an extraxtion string will be placed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Score (VAS)
Visual Analog Score (VAS) for flank pain and dysuria score, urgency, frequency, suprapubic pain, hematuria, analgesia requirement, operative time, re-hospitalization, and return to normal physical activity. This is a widely-used scale. It a unidimensional measure of pain intensity. It is administered as a straight horizontal line orientated from the left (worst) to the right (best) , where the patient indicates their situation.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start2 Feb 2016
- Primary completion1 Jun 2019
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureter StoneStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saddam Al Demour, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145063
- Sponsor's protocol ID
- Sad2019
- Status last verified
- Aug 2021
- First submitted
- 28 Oct 2019
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ureteric Stenting Versus Non-stenting Following Uncomplicated Ureteroscopic Lithotripsy: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT04145063
- Acronym / sponsor ID
- Sad2019
- Conditions
- Ureter Stone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 2 Feb 2016 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 30 Oct 2019 (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.
This study aims to compare three groups of patients who underwent uncomplicated ureteroscopic lithotripsy (URSL) to evaluate whether stents could be eliminated after the procedure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| uncomplicated ureteroscopic lithotripsy with DJ-US | No intervention | –Following uncomplicated uretroscopic lithotripsy, a double J uretric stent will be placed (usually the standard of care) |
| uncomplicated ureteroscopic lithotripsy without US | Active comparator | Other: no stentFollowing uncomplicated uretroscopic lithotripsy no uretric stent will be placed |
| uncomplicated ureteroscopic lithotripsy with DJ-US-string | No intervention | –Following uncomplicated uretroscopic lithotripsy, a double J uretric stent with an extraxtion string will be placed |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years or older
- unilateral ureteric stones managed by ureteroscopy
Key exclusion criteria (12 listed)
- Stone size < 2 cm
- bilateral ureteral stones
- incomplete stone removal due to impacted stones
- failed ureteroscopic access to the stone
- stone migration to the kidney
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 |
|---|---|---|
| no stentfollowing uretroscopy, no stent will be placed | Other | uncomplicated ureteroscopic lithotripsy without US |
Primary outcome
Visual Analog Score (VAS)
Time frame: 1 week
Visual Analog Score (VAS) for flank pain and dysuria score, urgency, frequency, suprapubic pain, hematuria, analgesia requirement, operative time, re-hospitalization, and return to normal physical activity. This is a widely-used scale. It a unidimensional measure of pain intensity. It is administered as a straight horizontal line orientated from the left (worst) to the right (best) , where the patient indicates their situation.
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 18 Aug 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing no stent in people with Ureter Stone, run by University of Jordan at 1 site in Jordan.
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 2 inclusion and 12 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 18 Aug 2021. 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 Jordan. 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?
Visual Analog Score (VAS) (time frame: 1 week). 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 18 Aug 2021.