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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Ureteral Calculi; Symptoms and Signs
• Intervention / Treatment: Other: Administration of USSQ Symptoms questionnaire after stent positioning

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Turin, Italy, 10126
    • AOU Città della Salute e della Scienza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: suture stent; suture stent positioning after ureteroscopy. Intervention: administration of USSQ questionnaire.	Other: Administration of USSQ Symptoms questionnaire after stent positioning; Administration of USSQ Symptoms questionnaire to patients with two different type of stents after ureteroscopy
Active Comparator: conventional double-J stent; conventional double-J stent positioning after ureteroscopy. Intervention: administration of USSQ questionnaire.	Other: Administration of USSQ Symptoms questionnaire after stent positioning; Administration of USSQ Symptoms questionnaire to patients with two different type of stents after ureteroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
USSQ domains' scores	to compare USSQ domains' scores of suture stent and double J group, 2 weeks after surgery	14 days
USSQ domains' scores	to compare USSQ domains' scores of suture stent and double J group, 2 days after surgery	2 days
USSQ single answers	to compare USSQ single answers of suture stent and double J group, 2 weeks after surgery	14 day
USSQ single answers	to compare USSQ single answers of suture stent and double J group, 2 days after surgery	2 days
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
complications and adverse events	to compare complications and adverse events of suture stent and double J group	2 weeks

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Investigators: Principal Investigator: Andrea Bosio, Azienda Ospedaliera Città della Salute e della Scienza di Torino

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2020
• Primary Completion (Actual): November 2, 2020
• Study Completion (Actual): December 16, 2020

Study Registration Dates

• First Submitted: November 11, 2017
• First Submitted That Met QC Criteria: November 11, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): December 30, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Pain; Ureteroscopy; Ureteral Calculi; Symptoms and Signs; Ureteral Stents
• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Ureteral Diseases; Urolithiasis; Urinary Calculi; Calculi; Ureteral Calculi; Ureterolithiasis
• Other Study ID Numbers: AOUCSSTURAB004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No