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

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Status

Completed

Conditions

Symptoms and Signs

Ureteral Calculi

Pain

Treatments

Other: Administration of USSQ Symptoms questionnaire after stent positioning

Study type

Interventional

Funder types

Other

Identifiers

NCT03344120

AOUCSSTURAB004

Details and patient eligibility

About

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.

Enrollment

84 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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