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

Urolithiasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04582019
• Other study ID #: 05/20-?
• Status: Completed
• Phase: N/A
• Start date: August 14, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: April 2022
• Source: St. Petersburg State Pavlov Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Urolithiasis

Intervention

Device:
• stent extraction
stent extraction using magnetic retriever or flexible cystoscope

Locations

Country	Name	City	State
Russian Federation	First Pavlov Saint Petersburg University	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
St. Petersburg State Pavlov Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stent-related symptoms (SRS)	Using USSQ to evaluate the difference of SRS in patients with different types of stent	30 days
Primary	Body pain	Using VASP to evaluate the pain level in patients with different types of stent extraction	30 days