UrolithiasisNCT04582019
Safety and Effectiveness of Ureteral DJ Stent With Magnet (Blackstar, Urotech) Removal Under Ultrasound Control
A study testing stent extraction in people with Urolithiasis, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.
Trial summary
Evaluation of safety and effectiveness of ureteral DJ stent with magnet (Blackstar, Urotech), severity of stent-association symptoms and pain level syndrome after stent extraction compared with stent extraction by flexible cystoscope Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Urolithiasis
- What is being tested?
- stent extraction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 14 Aug 2020to 1 Mar 2022
- 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 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age from 18 to 70 years
- males
- Indications for rigid or flexible URS
- ASA score: 1-3
Who cannot join
- Active urinary tract infection
- taking alpha-1 adreno and M-cholinoblockers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center Randomized, Controlled Study Evaluating Safety and Effectiveness of Ureteral dj Stent With Magnet (Blackstar, Urotech), Stent-related Symptoms and Pain Level After Stent Removal Compared With Conventional Stent Removal With Flexible Cystoscope
Evaluation of safety and effectiveness of ureteral DJ stent with magnet (Blackstar, Urotech), severity of stent-association symptoms and pain level syndrome after stent extraction compared with stent extraction by flexible cystoscope
Read the detailed description
Inclusion Criteria:
- age from 18 to 70 years
- males
- Indications for rigid or flexible URS
- ASA score: 1-3
Exclusion Criteria:
- Active urinary tract infection
- taking alpha-1 adreno and M-cholinoblockers
All patients will be randomized into 2 groups:
- group A - male patients who will undergo ureteral stent placement by conventional polyurethane DJ stent, Fr 6.5. N=30
- group B - male patients who will undergo ureteral stent placement by polyurethane DJ stent with magnet (Blackstar, Urotech ), Fr 7. N=30 Patients are to be assigned a randomization number that will match their treatment. Block randomization using 10 blocks is to be performed by a central randomization organization (www.randomize.net) using a computerized algorithm.
Using the Visual Analog Scale of Pain (VASP) and Ureteric Stent Symptom Questionnaire (USSQ) we are going to assess the pain syndrome and the severity of stent-associated symptoms. The USSQ will be filled twice: 3 days after stent placement and on the day of stent removal, just before the procedure. All stents will be removed 30 days after placement. Also, immediately after stent removal, patients will complete the VASP questionnaire. In the control group, the stent will be removed using flexible cystoscopy. In the experimental group under ultrasound control using a magnetic retriever, with a bladder capacity of at least 150 ml.
Primary assessed outcomes:
- Age
- Body mass index
- Operation side
- The density of the stone
- Type of the operation
- Applying of the ureteral accessing sheath
- Type of the ureteral stent
- Troubles with stent placement
- USSQ (Ureteral stent symptom questionnaire) 3 days after surgery
- USSQ before stent extraction
- VASP (Visual Analog Scale Pain) immediately after stent extraction
- Duration of stent extractiom by magnetic retrieval device
- Duration of stent extraction by cystoscopy
- Stent removal success (yes/no)
Secondary assessed outcomes:
- Assessment of Stone-free status after surgery by performing computed tomography of kidneys and urinary tract without intravenous contrasting 1 month after surgery
- Stent encrustation
- Conditions
- Urolithiasis
- Being tested
- stent extraction
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stent extractionDevice
stent extraction using magnetic retriever or flexible cystoscope
| Study group | Role | What they receive |
|---|---|---|
| Patients with polyurethane DJ stent | Active comparator | Polyurethane DJ stent, 6Fr. The stent will be removed using flexible cystoscopy. Receives: Device: stent extraction |
| Patients with polyurethane DJ stent with magnet | Active comparator | Polyurethane DJ stent with magnet (Blackstar, Urotech), 7Fr. The stent will be removed under ultrasound control using a magnetic retriever Receives: Device: stent extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent-related symptoms (SRS)
Using USSQ to evaluate the difference of SRS in patients with different types of stent
Measured: 30 days
Body pain
Using VASP to evaluate the pain level in patients with different types of stent extraction
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start14 Aug 2020
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
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.
- 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
- * group A - male patients who will undergo ureteral stent placement by conventional polyurethane DJ stent, Fr 6.5. N=30 * group B - male patients who will undergo ureteral stent placement by polyurethane DJ stent with magnet (Blackstar, Urotech ), Fr 7. N=30
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Petersburg State Pavlov Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nariman.gadjiev, St. Petersburg State Pavlov Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582019
- Sponsor's protocol ID
- 05/20-н
- Status last verified
- Apr 2022
- First submitted
- 25 Sep 2020
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Randomized, Controlled Study Evaluating Safety and Effectiveness of Ureteral dj Stent With Magnet (Blackstar, Urotech), Stent-related Symptoms and Pain Level After Stent Removal Compared With Conventional Stent Removal With Flexible Cystoscope
- ClinicalTrials.gov ID
- NCT04582019
- Acronym / sponsor ID
- 05/20-н
- Conditions
- Urolithiasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- St. Petersburg State Pavlov Medical UniversityUniversity, hospital or other
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 9 Oct 2020 (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.
Evaluation of safety and effectiveness of ureteral DJ stent with magnet (Blackstar, Urotech), severity of stent-association symptoms and pain level syndrome after stent extraction compared with stent extraction by flexible cystoscope
Detailed description
Inclusion Criteria:
- age from 18 to 70 years
- males
- Indications for rigid or flexible URS
- ASA score: 1-3
Exclusion Criteria:
- Active urinary tract infection
- taking alpha-1 adreno and M-cholinoblockers
All patients will be randomized into 2 groups:
- group A - male patients who will undergo ureteral stent placement by conventional polyurethane DJ stent, Fr 6.5. N=30
- group B - male patients who will undergo ureteral stent placement by polyurethane DJ stent with magnet (Blackstar, Urotech ), Fr 7. N=30 Patients are to be assigned a randomization number that will match their treatment. Block randomization using 10 blocks is to be performed by a central randomization organization (www.randomize.net) using a computerized algorithm.
Using the Visual Analog Scale of Pain (VASP) and Ureteric Stent Symptom Questionnaire (USSQ) we are going to assess the pain syndrome and the severity of stent-associated symptoms. The USSQ will be filled twice: 3 days after stent placement and on the day of stent removal, just before the procedure. All stents will be removed 30 days after placement. Also, immediately after stent removal, patients will complete the VASP questionnaire. In the control group, the stent will be removed using flexible cystoscopy. In the experimental group under ultrasound control using a magnetic retriever, with a bladder capacity of at least 150 ml.
Primary assessed outcomes:
- Age
- Body mass index
- Operation side
- The density of the stone
- Type of the operation
- Applying of the ureteral accessing sheath
- Type of the ureteral stent
- Troubles with stent placement
- USSQ (Ureteral stent symptom questionnaire) 3 days after surgery
- USSQ before stent extraction
- VASP (Visual Analog Scale Pain) immediately after stent extraction
- Duration of stent extractiom by magnetic retrieval device
- Duration of stent extraction by cystoscopy
- Stent removal success (yes/no)
Secondary assessed outcomes:
- Assessment of Stone-free status after surgery by performing computed tomography of kidneys and urinary tract without intravenous contrasting 1 month after surgery
- Stent encrustation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- * group A - male patients who will undergo ureteral stent placement by conventional polyurethane DJ stent, Fr 6.5. N=30 * group B - male patients who will undergo ureteral stent placement by polyurethane DJ stent with magnet (Blackstar, Urotech ), Fr 7. N=30
| Arm | Type | Receives |
|---|---|---|
| Patients with polyurethane DJ stent | Active comparator | Device: stent extractionPolyurethane DJ stent, 6Fr. The stent will be removed using flexible cystoscopy. |
| Patients with polyurethane DJ stent with magnet | Active comparator | Device: stent extractionPolyurethane DJ stent with magnet (Blackstar, Urotech), 7Fr. The stent will be removed under ultrasound control using a magnetic retriever |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age from 18 to 70 years
- males
- Indications for rigid or flexible URS
- ASA score: 1-3
Key exclusion criteria (2 listed)
- Active urinary tract infection
- taking alpha-1 adreno and M-cholinoblockers
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 |
|---|---|---|
| stent extractionstent extraction using magnetic retriever or flexible cystoscope | Device | Patients with polyurethane DJ stent, Patients with polyurethane DJ stent with magnet |
Primary outcome
Stent-related symptoms (SRS)
Time frame: 30 days
Using USSQ to evaluate the difference of SRS in patients with different types of stent
Body pain
Time frame: 30 days
Using VASP to evaluate the pain level in patients with different types of stent extraction
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 13 Apr 2022.
- Individual participant dataSharing planned: No
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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 stent extraction in people with Urolithiasis, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.
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 2 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 13 Apr 2022. 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 Russia. 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?
Stent-related symptoms (SRS) (time frame: 30 days). The study lists 2 primary outcomes in all. 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 13 Apr 2022.