Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Inclusion Criteria:
Exclusion Criteria:
All patients will be randomized into 2 groups:
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:
Secondary assessed outcomes:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with polyurethane DJ stent | Active Comparator | Polyurethane DJ stent, 6Fr. The stent will be removed using flexible cystoscopy. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stent extraction | Device | stent extraction using magnetic retriever or flexible cystoscope |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Pavlov Saint Petersburg University | Saint Petersburg | 197342 | Russia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D052878 | Urolithiasis |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
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.
| D052801 | Male Urogenital Diseases |