NCT02489656

Brief Summary

This study is a prospective, randomized multicenter study conducted in Europe. It is designed to compare two double loop ureteral stents in terms of the quality of life in patients operated on a kidney stone and requiring the placement of a double loop ureteral stent at the end of the operation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 1, 2013

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 3, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 3, 2015

Status Verified

May 1, 2015

Enrollment Period

3.3 years

First QC Date

May 18, 2015

Last Update Submit

July 1, 2015

Conditions

Kidney Calculi

Keywords

Double loop ureteral stentUSSQQuality of lifePain

Outcome Measures

Primary Outcomes (1)

  • USSQ scale (Ureteral Stent Symptoms Questionnaire)

    at day 20

Secondary Outcomes (1)

  • Evaluate impact on quality of life via the USSQ questionnaire assessing 5 other scores and adverse event reporting at all visits.

    Day 2, 7 and 35

Other Outcomes (1)

  • Encrustation of double loop ureteral stents

    after 20 days (JJ stent removal)

Study Arms (2)

Coloplast Hydrocoated silicone JJ stent

EXPERIMENTAL

Double loop ureteral stent endoscopic placement

Device: Double Loop Ureteral stent endoscopic placement.

Boston Percuflex Plus JJ stent

ACTIVE COMPARATOR

Double loop ureteral stent endoscopic placement

Device: Double Loop Ureteral stent endoscopic placement.

Interventions

Double Loop Ureteral stent endoscopic placement.DEVICE

A JJ stent placement may be indicated at the end of the endourological removal of kidney stones to ensure urine drainage and cicatrisation

Boston Percuflex Plus JJ stentColoplast Hydrocoated silicone JJ stent

Eligibility Criteria

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

You may qualify if:

  • Male and female patients
  • Aged \> 18 years
  • Unilateral renal non-infection stone for whom the treatment indication is a flexible ureterorenoscopy (multiple kidney stones are acceptable provided that only one side is currently symptomatic)
  • Index stone of 5-25 mm (measured on plain abdomen X-Ray KUB or CT)
  • Without any currently implanted JJ stent
  • Patient agreed to participate to the study and having signed the consent form
  • Able to complete self-rated questionnaires.

You may not qualify if:

  • Acute ureteric/nephritic colic (residual pain is acceptable)
  • Any type of chronic pain
  • Large stones \> 25 mm
  • Infection renal stone already diagnosed and documented
  • Malformation of urinary tract (e.g. Horseshoe kidney, duplicity or, ureterocele, mega ureter)
  • Diverticulum stone
  • Urogenital tumor
  • Any significant neurological disease or injury impacting sensation
  • JJ stents already implanted
  • Patients with long-term indwelling urethral catheter
  • No indication for JJ insertion (e.g. spontaneous stone passage)
  • Untreated urinary tract infection
  • Ureteral obstruction (stenosis, compression, calculi)
  • Neurogenic bladder
  • Overactive bladder
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Chirurgie Urologique de l'Hôpital Tenon

Paris, 75020, France

RECRUITING

MeSH Terms

Conditions

Kidney CalculiPain

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Olivier PJ Traxer, Professor

    Service de Chirurgie Urologique de l'Hôpital Tenon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pascale HS Holliday, CTM

CONTACT

+33 1 40 83 68 58frpho@coloplast.com

Dorothee Behr, Med Manager

CONTACT

+33 1 40 83 68 50frdbe@coloplast.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2015

First Posted

July 3, 2015

Study Start

September 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

July 3, 2015

Record last verified: 2015-05

Locations

FR(1)