UrolithiasisNCT06749652
Prospective, Randomized Trial Comparing Soft and Firm Ureteral Stents
A study testing firm silicone stent insertion and Soft silicone ureteral stent insertion in people with Urolithiasis, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The goal of this clinical trial is to evaluate whether ureteral stent type impacts stent-related symptoms and quality of life in patients undergoing ureteroscopy (URS) and stone lithotripsy for ureteral stones. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urolithiasis
- What is being tested?
- firm silicone stent insertion and Soft silicone ureteral stent insertion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- 9 Jul 2023to 10 Sep 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged over 18 years
- ureteral stones measuring up to 2cm requiring URS and laser lithotripsy
Who cannot join
- pediatric patients
- bilateral stones requiring bilateral URS and laser lithotripsy,
- stone located in the renal pelvis or calyces,
- intra-operative complications of any kind,
- any residual stones during the procedure,
- ureteroscopies in which no stones were treated ("white ureteroscopy").
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Soft Vs. Firm Ureteral Stents: Symptoms Improvement Without Affecting Outcomes- a Prospective, Randomized Trial
The goal of this clinical trial is to evaluate whether ureteral stent type impacts stent-related symptoms and quality of life in patients undergoing ureteroscopy (URS) and stone lithotripsy for ureteral stones. The main questions it aims to answer are:
- Does a soft polymer stent reduce stent-related symptoms compared to a firm polymer stent?
- Does stent type affect intra- and postoperative complications? Researchers will compare patients receiving a soft polymer stent (Universa®, Cook Medical) to those receiving a firm polymer stent (Percuflex®, Boston Scientific) to determine if soft stents improve patient comfort and quality of life while maintaining a similar safety profile.
Read more
Participants will:
- Undergo URS and stone lithotripsy for ureteral stones.
- Be randomly assigned to receive either a soft or firm ureteral stent.
- Complete the Ureteral Stent Symptoms Questionnaire (USSQ) upon stent removal, 14 days after URS.
Read the detailed description
Study Design and Patient Selection
- Study Period and Ethical Approval:
- Conducted between July 2023 and July 2024 following institutional review board approval (SMC 0119-23).
- Informed consent obtained from all participants.
- Adhered to the Declaration of Helsinki.
- Stent Types and Randomization:
- Soft stent: Universa® (Cook Medical).
- Firm stent: Percuflex™ Plus (Boston Scientific).
- Randomization in a 1:1 ratio using asymptomatic maximal randomization.
Surgical Technique and Intervention Operative Team included three fellowship-trained endourologists.
Procedure Details:
- Ureteroscopy performed using standard 6.5/8.5Fr semi-rigid ureteroscope.
- Lithotripsy performed using a 120W Holmium:YAG laser (0.3 Joule, 40 Hertz, dusting technique).
Stent Placement was performed using a 0.038 Inch glide wire. 6Fr stents used, either soft or firm polymer material, according to randomization.
Proximal stent curls positioned in the upper calyx/renal pelvis; distal curls in the bladder.
Postoperative Care Stent removal was scheduled 2 weeks post-procedure, ans performed using a flexible cystoscope in the outpatient clinic.
Symptoms assesed using the Ureteral Stent Symptoms Questionnaire (USSQ) that was completed at the stent removal visit.
Statistical Analysis
- Sample Size Calculation:
- Based on a 3-point difference in USSQ index score between groups.
- Assumed 5% type I error and 80% power.
- Adjusted for a 10% dropout rate; target sample size: 140 patients.
- Data Blinding:
- Patients, data collectors, and analysts blinded to allocation.
- Since blinding the surgeons to stent type was impossible, surgeons were not involved in data collection or analysis.
- Analysis Methods:
- Continuous variables: Mann-Whitney U test; median and IQR.
- Categorical variables: Pearson's chi-square or Fisher's exact test; frequencies and proportions.
- Multivariate linear regression for USSQ index and urinary domain scores.
- Statistical significance set at p<0.05.
- Analyses conducted using IBM SPSS v26.
This protocol ensures a rigorous and reproducible methodology for evaluating the impact of stent type on patient-reported outcomes following ureteroscopy and lithotripsy.
- Conditions
- Urolithiasis
- Being tested
- firm silicone stent insertion, Soft silicone ureteral stent insertion
- Keywords
- Urolithiasis, stent-symptoms
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
firm silicone stent insertionDevice
Also called percuflex plus
Insertion of firm silicon ureteral stent (Percuflex Plus)
Soft silicone ureteral stent insertionDevice
Also called Universa
Soft silicone ureteral stent insertion
| Study group | Role | What they receive |
|---|---|---|
| Soft silicone stent arm | Experimental | Patients who recieved soft silicone ureteral stent (Universa, Cook medical) at the end of the ureteroscopy Receives: Device: Soft silicone ureteral stent insertion |
| Firm silicone stent arm | Experimental | Patients who recieved firm silicone ureteral stent (percuflex plux, boston scientificl) at the end of the ureteroscopy Receives: Device: firm silicone stent insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Ureteral stent symptoms questionnaire (USSQ )index score
The summation of the Ureteral stent symptoms questionnaire (USSQ) individual question scores. The questionnaire includes 32 questions, with a scale of zero to five points each. The USSQ Index score represents the summation of each indivisual question score, with a scale of 0-160, with higher score means the patients is suffering from more severe symptoms.
Measured: 14 days after stent insertion
Secondary outcomes (5)
Ureteral stent symptoms questionnaire (USSQ) urinary domain score
There are total of 5 different domains in the Ureteral stent symptoms questionnaire (USSQ): urinary synptoms, pain, general health, occupational and sexual distress. The summation of the score of each domain represents a secondary outcome. The urinary domain has 10 questions, each in a scale of zero to five, to a total of 0-50. Higher score means the patient experience more severe urinary symptoms.
Measured: 14 days after stent insertion
Ureteral stent symptoms questionnaire (USSQ) pain domain score
There are total of 5 different domains in the Ureteral stent symptoms questionnaire (USSQ): urinary synptoms, pain, general health, occupational and sexual distress. The summation of the score of each domain represents a secondary outcome. The pain domain has 7 questions, each in a scale of zero to five, to a total of 0-35. Higher score means the patient experience more severe pain.
Measured: 14 days after stent insertion
Ureteral stent symptoms questionnaire (USSQ) general health domain score
There are total of 5 different domains in the Ureteral stent symptoms questionnaire (USSQ): urinary synptoms, pain, general health, occupational and sexual distress. The summation of the score of each domain represents a secondary outcome. The general health domain has 6 questions, each in a scale of zero to five, to a total of 0-30. Higher score means the stent affecting the patients general health in a more prominent way.
Measured: 14 days after stent insertion
Ureteral stent symptoms questionnaire (USSQ) work performance domain score
There are total of 5 different domains in the Ureteral stent symptoms questionnaire (USSQ): urinary synptoms, pain, general health, occupational and sexual distress. The summation of the score of each domain represents a secondary outcome. The work performance domain has 6 questions, each in a scale of zero to five, to a total of 0-30. Higher score means the stent affecting the patients work performance in a more prominent way.
Measured: 14 days after stent insertion
Ureteral stent symptoms questionnaire (USSQ) sexual performance domain score
There are total of 5 different domains in the Ureteral stent symptoms questionnaire (USSQ): urinary synptoms, pain, general health, occupational and sexual distress. The summation of the score of each domain represents a secondary outcome. The sexual performance domain has three questions, each in a scale of zero to five, to a total of 0-15. Higher score means the stent affecting the patients sexual performance in a more prominent way.
Measured: 14 days after stent insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start9 Jul 2023
- Primary completion10 Sep 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel model has been used. The randomization allocation sequence (1:1) has been generated using asymptomatic maximal randomization. Patients, data collectors and data analysts were blinded to the allocation. As blinding the surgeons during procedure was not possible, they were not involved in either data collection or analysis.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Orel Hemo, Sheba Medical Center
- Investigators
- Nir Kleinmann, M.D., Study director, Sheba Medical Center, Tel-Hashomer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749652
- Sponsor's protocol ID
- 0119-23-SMC
- Status last verified
- Dec 2024
- First submitted
- 15 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Upon reasonable request, an anonimized version will be shared
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft Vs. Firm Ureteral Stents: Symptoms Improvement Without Affecting Outcomes- a Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT06749652
- Acronym / sponsor ID
- 0119-23-SMC
- Conditions
- Urolithiasis
- Keywords
- Urolithiasis, stent-symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 9 Jul 2023 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 27 Dec 2024 (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.
The goal of this clinical trial is to evaluate whether ureteral stent type impacts stent-related symptoms and quality of life in patients undergoing ureteroscopy (URS) and stone lithotripsy for ureteral stones. The main questions it aims to answer are:
- Does a soft polymer stent reduce stent-related symptoms compared to a firm polymer stent?
- Does stent type affect intra- and postoperative complications? Researchers will compare patients receiving a soft polymer stent (Universa®, Cook Medical) to those receiving a firm polymer stent (Percuflex®, Boston Scientific) to determine if soft stents improve patient comfort and quality of life while maintaining a similar safety profile.
Participants will:
- Undergo URS and stone lithotripsy for ureteral stones.
- Be randomly assigned to receive either a soft or firm ureteral stent.
- Complete the Ureteral Stent Symptoms Questionnaire (USSQ) upon stent removal, 14 days after URS.
Detailed description
Study Design and Patient Selection
- Study Period and Ethical Approval:
- Conducted between July 2023 and July 2024 following institutional review board approval (SMC 0119-23).
- Informed consent obtained from all participants.
- Adhered to the Declaration of Helsinki.
- Stent Types and Randomization:
- Soft stent: Universa® (Cook Medical).
- Firm stent: Percuflex™ Plus (Boston Scientific).
- Randomization in a 1:1 ratio using asymptomatic maximal randomization.
Surgical Technique and Intervention Operative Team included three fellowship-trained endourologists.
Procedure Details:
- Ureteroscopy performed using standard 6.5/8.5Fr semi-rigid ureteroscope.
- Lithotripsy performed using a 120W Holmium:YAG laser (0.3 Joule, 40 Hertz, dusting technique).
Stent Placement was performed using a 0.038 Inch glide wire. 6Fr stents used, either soft or firm polymer material, according to randomization.
Proximal stent curls positioned in the upper calyx/renal pelvis; distal curls in the bladder.
Postoperative Care Stent removal was scheduled 2 weeks post-procedure, ans performed using a flexible cystoscope in the outpatient clinic.
Symptoms assesed using the Ureteral Stent Symptoms Questionnaire (USSQ) that was completed at the stent removal visit.
Statistical Analysis
- Sample Size Calculation:
- Based on a 3-point difference in USSQ index score between groups.
- Assumed 5% type I error and 80% power.
- Adjusted for a 10% dropout rate; target sample size: 140 patients.
- Data Blinding:
- Patients, data collectors, and analysts blinded to allocation.
- Since blinding the surgeons to stent type was impossible, surgeons were not involved in data collection or analysis.
- Analysis Methods:
- Continuous variables: Mann-Whitney U test; median and IQR.
- Categorical variables: Pearson's chi-square or Fisher's exact test; frequencies and proportions.
- Multivariate linear regression for USSQ index and urinary domain scores.
- Statistical significance set at p<0.05.
- Analyses conducted using IBM SPSS v26.
This protocol ensures a rigorous and reproducible methodology for evaluating the impact of stent type on patient-reported outcomes following ureteroscopy and lithotripsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel model has been used. The randomization allocation sequence (1:1) has been generated using asymptomatic maximal randomization. Patients, data collectors and data analysts were blinded to the allocation. As blinding the surgeons during procedure was not possible, they were not involved in either data collection or analysis.
| Arm | Type | Receives |
|---|---|---|
| Soft silicone stent arm | Experimental | Device: Soft silicone ureteral stent insertionPatients who recieved soft silicone ureteral stent (Universa, Cook medical) at the end of the ureteroscopy |
| Firm silicone stent arm | Experimental | Device: firm silicone stent insertionPatients who recieved firm silicone ureteral stent (percuflex plux, boston scientificl) at the end of the ureteroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients aged over 18 years
- ureteral stones measuring up to 2cm requiring URS and laser lithotripsy
Key exclusion criteria (6 listed)
- pediatric patients
- bilateral stones requiring bilateral URS and laser lithotripsy,
- stone located in the renal pelvis or calyces,
- intra-operative complications of any kind,
- any residual stones during the procedure,
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 |
|---|---|---|
| firm silicone stent insertionAlso: percuflex plusInsertion of firm silicon ureteral stent (Percuflex Plus) | Device | Firm silicone stent arm |
| Soft silicone ureteral stent insertionAlso: UniversaSoft silicone ureteral stent insertion | Device | Soft silicone stent arm |
Primary outcome
the Ureteral stent symptoms questionnaire (USSQ )index score
Time frame: 14 days after stent insertion
The summation of the Ureteral stent symptoms questionnaire (USSQ) individual question scores. The questionnaire includes 32 questions, with a scale of zero to five points each. The USSQ Index score represents the summation of each indivisual question score, with a scale of 0-160, with higher score means the patients is suffering from more severe symptoms.
5 secondary outcomes
Ureteral stent symptoms questionnaire (USSQ) urinary domain score
Time frame: 14 days after stent insertion
Ureteral stent symptoms questionnaire (USSQ) pain domain score
Time frame: 14 days after stent insertion
Ureteral stent symptoms questionnaire (USSQ) general health domain score
Time frame: 14 days after stent insertion
Ureteral stent symptoms questionnaire (USSQ) work performance domain score
Time frame: 14 days after stent insertion
Ureteral stent symptoms questionnaire (USSQ) sexual performance domain score
Time frame: 14 days after stent insertion
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 27 Dec 2024.
- Individual participant dataSharing planned: Yes. Upon reasonable request, an anonimized version will be shared
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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.
Nir Kleinmann, M.D. study director
Sheba Medical Center, Tel-Hashomer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing firm silicone stent insertion and Soft silicone ureteral stent insertion in people with Urolithiasis, run by Sheba Medical Center at 1 site in Israel.
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 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 27 Dec 2024. 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 Israel. 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?
the Ureteral stent symptoms questionnaire (USSQ )index score (time frame: 14 days after stent insertion). 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 27 Dec 2024.