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
• Interventions: Other: Administration of USSQ Symptoms questionnaire after stent positioning

• 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

Arm && Interventions

Group	Intervention	Description
suture stent	Administration of USSQ Symptoms questionnaire after stent positioning	suture stent positioning after ureteroscopy. Intervention: administration of USSQ questionnaire.
conventional double-J stent	Administration of USSQ Symptoms questionnaire after stent positioning	conventional double-J stent positioning after ureteroscopy. Intervention: administration of USSQ questionnaire.

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