NCT03344120

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
2.1 years until next milestone

Study Start

First participant enrolled

January 8, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2020

Completed
Last Updated

December 30, 2020

Status Verified

December 1, 2020

Enrollment Period

10 months

First QC Date

November 11, 2017

Last Update Submit

December 28, 2020

Conditions

Symptoms and SignsPainUreteral Calculi

Keywords

Symptoms and SignsPainUreteral CalculiUreteroscopyUreteral Stents

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • USSQ domains' scores

    14 days

  • USSQ domains' scores

    2 days

  • USSQ single answers

    14 day

  • USSQ single answers

    2 days

  • 2 weeks USSQ domains' subscores adjusted for baseline

    6 weeks

  • +1 more secondary outcomes

Study Arms (2)

suture stent

ACTIVE COMPARATOR

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

Other: Administration of USSQ Symptoms questionnaire after stent positioning

conventional double-J stent

ACTIVE COMPARATOR

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

Other: Administration of USSQ Symptoms questionnaire after stent positioning

Interventions

Administration of USSQ Symptoms questionnaire after stent positioningOTHER

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

conventional double-J stentsuture stent

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOU Città della Salute e della Scienza

Turin, 10126, Italy

Location

Related Publications (1)

  • 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: 34337527DERIVED

MeSH Terms

Conditions

Signs and SymptomsPainUreteral Calculi

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and SymptomsNeurologic ManifestationsUreterolithiasisUreteral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, Anatomical

Study Officials

  • Andrea Bosio

    A.O.U. Città della Salute e della Scienza

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD Urologist, PhD

Study Record Dates

First Submitted

November 11, 2017

First Posted

November 17, 2017

Study Start

January 8, 2020

Primary Completion

November 2, 2020

Study Completion

December 16, 2020

Last Updated

December 30, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)