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

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

Study Overview

• Status: Completed
• Conditions: Urolithiasis
• Intervention / Treatment: Device: stent extraction

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Saint Petersburg, Russian Federation, 197342
    • First Pavlov Saint Petersburg University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: St. Petersburg State Pavlov Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2020
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: September 25, 2020
• First Submitted That Met QC Criteria: October 3, 2020
• First Posted (Actual): October 9, 2020

Study Record Updates

• Last Update Posted (Actual): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urolithiasis
• Other Study ID Numbers: 05/20-н

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No