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OpenTrials
Completed

NCT Number: NCT04582019

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

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

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Key information

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

First Pavlov Saint Petersburg University

Saint Petersburg, 197342, Russia

About this study

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:

  • Age
  • Body mass index
  • Operation side
  • The density of the stone
  • Type of the operation
  • Applying of the ureteral accessing sheath
  • Type of the ureteral stent
  • Troubles with stent placement
  • USSQ (Ureteral stent symptom questionnaire) 3 days after surgery
  • USSQ before stent extraction
  • VASP (Visual Analog Scale Pain) immediately after stent extraction
  • Duration of stent extractiom by magnetic retrieval device
  • Duration of stent extraction by cystoscopy
  • Stent removal success (yes/no)

Secondary assessed outcomes:

  • Assessment of Stone-free status after surgery by performing computed tomography of kidneys and urinary tract without intravenous contrasting 1 month after surgery
  • Stent encrustation

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

stent extraction

Device

stent extraction using magnetic retriever or flexible cystoscope

Primary outcomes

  1. Stent-related symptoms (SRS)

    Time frame: 30 days

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

  2. Body pain

    Time frame: 30 days

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

Sponsors and collaborators

Lead sponsor

St. Petersburg State Pavlov Medical University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 9, 2020
Registry last updated
Apr 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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