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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04582019
Enrollment
60
Registered
2020-10-09
Start date
2020-08-14
Completion date
2022-03-01
Last updated
2022-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urolithiasis

Brief 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

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: 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

Interventions

DEVICEstent extraction

stent extraction using magnetic retriever or flexible cystoscope

Sponsors

St. Petersburg State Pavlov Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Masking description

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.

Intervention 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

Eligibility

Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Stent-related symptoms (SRS)30 daysUsing USSQ to evaluate the difference of SRS in patients with different types of stent
Body pain30 daysUsing VASP to evaluate the pain level in patients with different types of stent extraction

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026