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Clinical Trials/NCT04582019
NCT04582019
Completed
Not Applicable

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

St. Petersburg State Pavlov Medical University1 site in 1 country60 target enrollmentAugust 14, 2020
ConditionsUrolithiasis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urolithiasis
Sponsor
St. Petersburg State Pavlov Medical University
Enrollment
60
Locations
1
Primary Endpoint
Body pain
Status
Completed
Last Updated
4 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
August 14, 2020
End Date
March 1, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
St. Petersburg State Pavlov Medical University
Responsible Party
Principal Investigator
Principal Investigator

nariman.gadjiev

Head of endourology department

St. Petersburg State Pavlov Medical University

Eligibility Criteria

Inclusion Criteria

  • age from 18 to 70 years
  • Indications for rigid or flexible URS
  • ASA score: 1-3

Exclusion Criteria

  • Active urinary tract infection
  • taking alpha-1 adreno and M-cholinoblockers

Outcomes

Primary Outcomes

Body pain

Time Frame: 30 days

Using VASP to evaluate the pain level in patients with different types of stent extraction

Stent-related symptoms (SRS)

Time Frame: 30 days

Using USSQ to evaluate the difference of SRS in patients with different types of stent

Study Sites (1)

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