OPTIMAL STENTS DURING RENAL COLIC

Ureteral Stent Occlusion Clinical Trial

Official title:

COMPARISON OF SILICONE VERSUS POLYURETHANE URETERAL STENTS: A PROSPECTIVE CONTROLLED STUDY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04000178
• Other study ID #: 217
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: October 10, 2018

Study information

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

Clinical Trial Summary

From June 2018 to October 2018, patients from two distinct clinical centers were prospectively enrolled in the study and stratified (non-randomly) into either control group A, patients who received polyurethane stents (Rüsch, Teleflex), or experimental group B, patients who received silicone stents (Cook Medical). Each participant completed a survey one hour after stent insertion, in the middle of the stent dwelling period, and before stent removal or ureteroscopy noting body pain and overactive bladder via the visual analog scale pain (VASP) and overactive bladder (OAB) awareness tool, respectively. Additionally, the successfulness of stent placement, hematuria, number of unplanned visits, and stent encrustation rates were assessed within each group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 10, 2018
• Est. primary completion date: October 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Inclusion criteria included age (18 to 60 years old),
• confirmed ureteral stone
• prescribed ureteral stent placement for pain syndrome relief

Exclusion Criteria:

• an active urinary tract infection.

Related Conditions & MeSH terms

• Ureteral Stent Occlusion

Intervention

Device:
• polyurethane stent
patients were prospectively enrolled in the study and stratified (non-randomly) into either group A - polyurethane - control group or group B - silicone - experimental group
• silicone stent
silicone stent

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	body pain	At each follow-up appointment, patients completed a survey in which the visual analog scale pain (VASP) was filled	4 weeks
Primary	bladder overactivity	At each follow-up appointment, patients completed a survey in which the "bladder awareness tool" (VASP) was filled	4 weeks