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

NCT03344120 — Not applicable, Completed, 84 participants, A.O.U. Città della Salute e della Scienza

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Comparison Between Symptomps Related to Pigtail Suture Stent Versus Conventional Double J After Ureterorenoscopy for Stone Treatment. A Prospective Randomized Trial

Registry	NCT03344120
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	84 (Actual)
Sponsor	A.O.U. Città della Salute e della Scienza (Other)
Conditions	Symptoms and Signs, Pain, Ureteral Calculi
Interventions	Administration of USSQ Symptoms questionnaire after stent positioning (Other)
Dates	start 2020-01-08, primary completion 2020-11-02, completion 2020-12-16, first posted 2017-11-17, last updated 2020-12-30
Locations	1 site in Italy

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
suture stent	Active comparator	Other: Administration of USSQ Symptoms questionnaire after stent positioning	suture stent positioning after ureteroscopy. Intervention: administration of USSQ questionnaire.
conventional double-J stent	Active comparator	Other: Administration of USSQ Symptoms questionnaire after stent positioning	conventional double-J stent positioning after ureteroscopy. Intervention: administration of USSQ questionnaire.

Administration of USSQ Symptoms questionnaire after stent positioning (Other): Administration of USSQ Symptoms questionnaire to patients with two different type of stents after ureteroscopy

+Outcome measures

Primary outcomes

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 outcomes

USSQ domains' scores [14 days]: to compare USSQ domains' scores of suture stent and double J group, 2 weeks after surgery
USSQ domains' scores [2 days]: to compare USSQ domains' scores of suture stent and double J group, 2 days after surgery
USSQ single answers [14 day]: to compare USSQ single answers of suture stent and double J group, 2 weeks after surgery
USSQ single answers [2 days]: to compare USSQ single answers of suture stent and double J group, 2 days 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
complications and adverse events [2 weeks]: to compare complications and adverse events of suture stent and double J group

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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

+Locations (1)

Facility	City	Country	Status
AOU Città della Salute e della Scienza	Turin	Italy

+Publications

Results publication: Bosio A, Alessandria E, Agosti S, Vitiello F, Vercelli E, Bisconti A, Piana P, Fop F, Gontero P. Pigtail Suture Stents Significantly Reduce Stent-related Symptoms Compared to Conventional Double J Stents: A Prospective Randomized Trial. Eur Urol Open Sci. 2021 May 10;29:1-9. doi: 10.1016/j.euros.2021.03.011. eCollection 2021 Jul. PMID 34337527

+Investigators

Andrea Bosio, Principal investigator, A.O.U. Città della Salute e della Scienza