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

Primary Purpose

Symptoms and Signs, Pain, Ureteral Calculi

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Administration of USSQ Symptoms questionnaire after stent positioning

About this trial

This is an interventional treatment trial for Symptoms and Signs focused on measuring Symptoms and Signs, Pain, Ureteral Calculi, Ureteroscopy, Ureteral Stents

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

AOU Città della Salute e della Scienza

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

suture stent

conventional double-J stent

Arm Description

suture stent positioning after ureteroscopy. Intervention: administration of USSQ questionnaire.

conventional double-J stent positioning after ureteroscopy. Intervention: administration of USSQ questionnaire.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

USSQ domains' scores

to compare USSQ domains' scores of suture stent and double J group, 2 weeks after surgery

USSQ domains' scores

to compare USSQ domains' scores of suture stent and double J group, 2 days after surgery

USSQ single answers

to compare USSQ single answers of suture stent and double J group, 2 weeks after surgery

USSQ single answers

to compare USSQ single answers of suture stent and double J group, 2 days after surgery

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

complications and adverse events

to compare complications and adverse events of suture stent and double J group

Full Information

NCT ID

NCT03344120

First Posted

November 11, 2017

Last Updated

December 28, 2020

Sponsor

Azienda Ospedaliera Città della Salute e della Scienza di Torino

1. Study Identification

Unique Protocol Identification Number

NCT03344120

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

January 8, 2020 (Actual)

Primary Completion Date

November 2, 2020 (Actual)

Study Completion Date

December 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Azienda Ospedaliera Città della Salute e della Scienza di Torino

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Symptoms and Signs, Pain, Ureteral Calculi

Keywords

Symptoms and Signs, Pain, Ureteral Calculi, Ureteroscopy, Ureteral Stents

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

suture stent

Arm Type

Active Comparator

Arm Description

suture stent positioning after ureteroscopy. Intervention: administration of USSQ questionnaire.

Arm Title

conventional double-J stent

Arm Type

Active Comparator

Arm Description

conventional double-J stent positioning after ureteroscopy. Intervention: administration of USSQ questionnaire.

Intervention Type

Other

Intervention Name(s)

Administration of USSQ Symptoms questionnaire after stent positioning

Intervention Description

Administration of USSQ Symptoms questionnaire to patients with two different type of stents after ureteroscopy

Primary Outcome Measure Information:

Title

Urinary Symptom Index Score

Description

to compare Urinary Symptom Index Score (sum of USSQ Urinary symptoms scores) of suture stent and double J group, 2 weeks after surgery.

Time Frame

14 days

Secondary Outcome Measure Information:

Title

USSQ domains' scores

Description

to compare USSQ domains' scores of suture stent and double J group, 2 weeks after surgery

Time Frame

14 days

Title

USSQ domains' scores

Description

to compare USSQ domains' scores of suture stent and double J group, 2 days after surgery

Time Frame

2 days

Title

USSQ single answers

Description

to compare USSQ single answers of suture stent and double J group, 2 weeks after surgery

Time Frame

14 day

Title

USSQ single answers

Description

to compare USSQ single answers of suture stent and double J group, 2 days after surgery

Time Frame

2 days

Title

2 weeks USSQ domains' subscores adjusted for baseline

Description

to compare 2 weeks USSQ domains' subscores adjusted for baseline of suture stent and double J group

Time Frame

6 weeks

Title

complications and adverse events

Description

to compare complications and adverse events of suture stent and double J group

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrea Bosio

Organizational Affiliation

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Official's Role

Principal Investigator

Facility Information:

Facility Name

AOU Città della Salute e della Scienza

City

Turin

ZIP/Postal Code

10126

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34337527

Citation

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.

Results Reference

derived

Learn more about this trial

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

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