Safety and Effectiveness of Ureteral DJ Stent With Magnet (Blackstar, Urotech) Removal Under Ultrasound Control

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Urolithiasis

Intervention / Treatment
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* Device: stent extraction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients with polyurethane DJ stent<br>Polyurethane DJ stent, 6Fr. The stent will be removed using flexible cystoscopy. | Device: stent extraction<br>* stent extraction using magnetic retriever or flexible cystoscope<br>|
| Active Comparator: Patients with polyurethane DJ stent with magnet<br>Polyurethane DJ stent with magnet (Blackstar, Urotech), 7Fr. The stent will be removed under ultrasound control using a magnetic retriever | Device: stent extraction<br>* stent extraction using magnetic retriever or flexible cystoscope<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent-related symptoms (SRS) | Using USSQ to evaluate the difference of SRS in patients with different types of stent | 30 days | 
| Body pain | Using VASP to evaluate the pain level in patients with different types of stent extraction | 30 days |