Pain, Symptoms and Signs, Ureteral Calculi
Conditions
Keywords
Symptoms and Signs, Pain, Ureteral Calculi, Ureteroscopy, Ureteral Stents
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.
Interventions
OTHERAdministration of USSQ Symptoms questionnaire after stent positioning
Administration of USSQ Symptoms questionnaire to patients with two different type of stents after ureteroscopy
Sponsors
A.O.U. Città della Salute e della Scienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| USSQ single answers | 14 day | to compare USSQ single answers of suture stent and double J group, 2 weeks 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 |
| USSQ domains' scores | 14 days | to compare USSQ domains' scores of suture stent and double J group, 2 weeks after surgery |
| complications and adverse events | 2 weeks | to compare complications and adverse events of suture stent and double J group |
Countries
Italy
Outcome results
None listed