CompletedNot Applicable

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

Italy84 participantsStarted 2020-01-08

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Urinary Symptom Index Score

Timeframe: 14 days

Trial details

NCT IDNCT03344120

SponsorA.O.U. Città della Salute e della Scienza

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-11-02

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