Clinical trial NCT04582019: Safety and Effectiveness of Ureteral DJ Stent With Magnet (Blackstar, Urotech) Removal Under Ultrasound Control
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urolithiasis
Lead sponsor: St. Petersburg State Pavlov Medical University
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Stent-related symptoms (SRS)
timeFrame: 30 days
measure: Body pain
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: First Pavlov Saint Petersburg University
Study officials:
References: