Pain Clinical Trial
Official title:
Comparison Between Symptomps Related to Pigtail Suture Stent Versus Conventional Double J After Ureterorenoscopy for Stone Treatment. A Prospective Randomized Trial
Verified date | December 2020 |
Source | Azienda Ospedaliera Città della Salute e della Scienza di Torino |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 84 |
Est. completion date | December 16, 2020 |
Est. primary completion date | November 2, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | AOU Città della Salute e della Scienza | Turin |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Città della Salute e della Scienza di Torino |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 14 days | |
Secondary | USSQ domains' scores | to compare USSQ domains' scores of suture stent and double J group, 2 weeks after surgery | 14 days | |
Secondary | USSQ domains' scores | to compare USSQ domains' scores of suture stent and double J group, 2 days after surgery | 2 days | |
Secondary | USSQ single answers | to compare USSQ single answers of suture stent and double J group, 2 weeks after surgery | 14 day | |
Secondary | USSQ single answers | to compare USSQ single answers of suture stent and double J group, 2 days after surgery | 2 days | |
Secondary | 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 | 6 weeks | |
Secondary | complications and adverse events | to compare complications and adverse events of suture stent and double J group | 2 weeks |
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