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

NCT04582019 | Completed

• 1 other identifier: 05/20-н
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Urolithiasis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Patients with polyurethane DJ stent

ACTIVE COMPARATOR

Polyurethane DJ stent, 6Fr. The stent will be removed using flexible cystoscopy.

Device: stent extraction

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

Device: stent extraction

Interventions

stent extraction DEVICE

stent extraction using magnetic retriever or flexible cystoscope

Patients with polyurethane DJ stent; Patients with polyurethane DJ stent with magnet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• St. Petersburg State Pavlov Medical University: lead

Study Sites (1)

First Pavlov Saint Petersburg University

Saint Petersburg, 197342, Russia

Location

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of endourology department

Model Details: * 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

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: October 9, 2020
• Study Start: August 14, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)