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

A.O.U. Città della Salute e della Scienza84 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Symptoms and Signs Pain Ureteral Calculi

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Urinary Symptom Index Score

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

Time frame: 14 days

Secondary Outcomes

USSQ domains' scores

to compare USSQ domains' scores of suture stent and double J group, 2 weeks after surgery

Time frame: 14 days

USSQ domains' scores

to compare USSQ domains' scores of suture stent and double J group, 2 days after surgery

Time frame: 2 days

USSQ single answers

to compare USSQ single answers of suture stent and double J group, 2 weeks after surgery

Time frame: 14 day

USSQ single answers

to compare USSQ single answers of suture stent and double J group, 2 days after surgery

Time frame: 2 days

2 weeks USSQ domains' subscores adjusted for baseline

to compare 2 weeks USSQ domains' subscores adjusted for baseline of suture stent and double J group

Time frame: 6 weeks

complications and adverse events

to compare complications and adverse events of suture stent and double J group

Time frame: 2 weeks