Safety and Effectiveness of Ureteral DJ Stent With Magnet (Blackstar, Urotech) Removal Under Ultrasound Control
NCT ID: NCT04582019
Last Updated: 2022-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2020-08-14
2022-03-01
Brief Summary
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Detailed Description
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* 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:
1. Age
2. Body mass index
3. Operation side
4. The density of the stone
5. Type of the operation
6. Applying of the ureteral accessing sheath
7. Type of the ureteral stent
8. Troubles with stent placement
9. USSQ (Ureteral stent symptom questionnaire) 3 days after surgery
10. USSQ before stent extraction
11. VASP (Visual Analog Scale Pain) immediately after stent extraction
12. Duration of stent extractiom by magnetic retrieval device
13. Duration of stent extraction by cystoscopy
14. Stent removal success (yes/no)
Secondary assessed outcomes:
1. Assessment of Stone-free status after surgery by performing computed tomography of kidneys and urinary tract without intravenous contrasting 1 month after surgery
2. Stent encrustation
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* group B - male patients who will undergo ureteral stent placement by polyurethane DJ stent with magnet (Blackstar, Urotech ), Fr 7. N=30
TREATMENT
SINGLE
Study Groups
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Patients with polyurethane DJ stent
Polyurethane DJ stent, 6Fr. The stent will be removed using flexible cystoscopy.
stent extraction
stent extraction using magnetic retriever or flexible cystoscope
Patients with polyurethane DJ stent with magnet
Polyurethane DJ stent with magnet (Blackstar, Urotech), 7Fr. The stent will be removed under ultrasound control using a magnetic retriever
stent extraction
stent extraction using magnetic retriever or flexible cystoscope
Interventions
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stent extraction
stent extraction using magnetic retriever or flexible cystoscope
Eligibility Criteria
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Inclusion Criteria
* males
* Indications for rigid or flexible URS
* ASA score: 1-3
Exclusion Criteria
* taking alpha-1 adreno and M-cholinoblockers
18 Years
70 Years
MALE
No
Sponsors
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St. Petersburg State Pavlov Medical University
OTHER
Responsible Party
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nariman.gadjiev
Head of endourology department
Locations
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First Pavlov Saint Petersburg University
Saint Petersburg, , Russia
Countries
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Other Identifiers
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05/20-н
Identifier Type: -
Identifier Source: org_study_id
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