Symptoms Comparison: Suture-stent vs Conventional Double-J Stents After Ureterorenoscopy. A Prospective Randomized Trial

Not Applicable

Completed

• Conditions: Pain; Symptoms and Signs; Ureteral Calculi

• Registration Number: NCT03344120
• Lead Sponsor: A.O.U. Città della Salute e della Scienza

Brief Summary

Double J ureteral stents (DJ) are widely used in urological practice and commonly inserted after most of ureteroscopies. Stent-related symptoms (SRS) represent a major issue. Many research lines have been explored with the aim of decreasing SRS: Vogt et al. projected a self-made pigtail suture stent (PSS) replacing the distal pigtail with a 0.3 Fr suture reaching the bladder, showing decreased SRS and good tolerance. To date, these promising results hasn't been confirmed by a prospective randomized controlled trial (RCT) involving a marketed PSS. Thus, we designed a prospective single-blind RCT to compare SRS caused by marketed PSS and conventional DJ after uncomplicated URS for stone treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-11
• Study First Submitted QC: 2017-11-11
• Study First Posted: 2017-11-17
• Study Start: 2020-01-08
• Primary Completion: 2020-11-02
• Status Verified: 2020-12
• Study Completion: 2020-12-16
• Last Update Submitted: 2020-12-28
• Last Update Posted: 2020-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• ureteral or renal stones < 2 cm needing treatment through semirigid or flexible URS and laser lithotripsy
• stone-free procedure and absence of intraprocedural complications
• WHO performance status 0-2

Exclusion Criteria

• significant residual fragments at the end of the procedure
• intraprocedural complications (e.g. ureteral damage or stricture)
• indwelling double J stent
• acute kidney failure
• urinary tract infection
• urinary tract abnormalities
• pathologies or medications potentially influencing voiding pattern and pain perception

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Urinary Symptom Index Score	14 days	to compare Urinary Symptom Index Score (sum of USSQ Urinary symptoms scores) of suture stent and double J group, 2 weeks after surgery.

Secondary Outcome Measures

Name	Time	Method
complications and adverse events	2 weeks	to compare complications and adverse events of suture stent and double J group
USSQ single answers	2 days	to compare USSQ single answers of suture stent and double J group, 2 days after surgery
USSQ domains' scores	2 days	to compare USSQ domains' scores of suture stent and double J group, 2 days after surgery
2 weeks USSQ domains' subscores adjusted for baseline	6 weeks	to compare 2 weeks USSQ domains' subscores adjusted for baseline of suture stent and double J group

Trial Locations

Locations (1)

AOU Città della Salute e della Scienza; 🇮🇹 Turin, Italy