Quality of Life in Patients With Double Loop Ureteral Stent (JJ Silicone Hydrogel Study)

NCT ID: NCT02489656

Last Updated: 2015-07-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-12-31

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.

Detailed Description

• The double loop stents are used for both prevention and treatment of ureteral obstruction: They permit the interim internal bypass drainage of urine when obstruction in the ureter especially in cases of lithiasis or after surgical intervention on the upper urinary tract.
• There are many indications for double loop stent placement and population chosen for this study are adult patients with intra-renal calcium calculi of 7-20 mm in diameter for whom the treatment indication is a flexible ureterorenoscopy.
• The aims of the use of a double loop stent are to

• prevent complications (pain, infection) associated with the ureteral obstruction by any residual stone fragments, blood clot or local oedema generated by the intervention.
• preserve the renal function.
• facilitate healing process while limiting the risk of stenosis and probably reduce the rate of readmission after patients' discharge.
• Double loop Stent-related symptoms have a high prevalence and may affect over 80% of patients.
• Assessment tools are important to determine the symptoms intensity and allow for comparisons at different times. The Urinary Stent Symptom Questionnaire (USSQ) is the most adapted tool designed for this purpose.
• An ideal ureteral stent is expected to drain well, to be easy to insert and to be comfortable for the patients. The investigators designed a hydro-coated Silicone JJ stent with additional properties for improving patient's comfort.
• The investigators decided to perform a randomized clinical investigation to evaluate the Coloplast Hydrocoated Silicone JJ in comparison to the Boston Percuflex Plus JJ stent on patients' comfort.

Conditions

Kidney Calculi

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Coloplast Hydrocoated silicone JJ stent

Double loop ureteral stent endoscopic placement

Group Type: EXPERIMENTAL

Double Loop Ureteral stent endoscopic placement.

Intervention Type: 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 stent

Double loop ureteral stent endoscopic placement

Group Type: ACTIVE_COMPARATOR

Double Loop Ureteral stent endoscopic placement.

Intervention Type: DEVICE

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

Interventions

Double Loop Ureteral stent endoscopic placement.

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Male and female patients

2. Aged > 18 years

3. 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)

4. Index stone of 5-25 mm (measured on plain abdomen X-Ray KUB or CT)

5. Without any currently implanted JJ stent

6. Patient agreed to participate to the study and having signed the consent form

7. Able to complete self-rated questionnaires.

Exclusion Criteria

1. Acute ureteric/nephritic colic (residual pain is acceptable)

2. Any type of chronic pain

3. Large stones > 25 mm

4. Infection renal stone already diagnosed and documented

5. Malformation of urinary tract (e.g. Horseshoe kidney, duplicity or, ureterocele, mega ureter)

6. Diverticulum stone

7. Urogenital tumor

8. Any significant neurological disease or injury impacting sensation

9. JJ stents already implanted

10. Patients with long-term indwelling urethral catheter

11. No indication for JJ insertion (e.g. spontaneous stone passage)

12. Untreated urinary tract infection

13. Ureteral obstruction (stenosis, compression, calculi)

14. Neurogenic bladder

15. Overactive bladder

16. Bladder stone

17. Chronic prostatitis

18. BPH treated (recent initiation of 5 alpha-Reductase Inhibitor or Phytotherapeutic agents)

19. Ongoing Alpha-Blocker or Anticholinergic medication

20. Pregnancy

21. Any event discovered during the endoscopy which is not compatible with the study design and objective

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coloplast A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivier PJ Traxer, Professor

Role: PRINCIPAL_INVESTIGATOR

Service de Chirurgie Urologique de l'Hôpital Tenon

Locations

Service de Chirurgie Urologique de l'Hôpital Tenon

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Pascale HS Holliday, CTM

Role: CONTACT

frpho@coloplast.com

+33 1 40 83 68 58

Dorothee Behr, Med Manager

Role: CONTACT

frdbe@coloplast.com

+33 1 40 83 68 50

Facility Contacts

Olivier PJ Traxer, Professor

Role: primary

olivier.traxer@tnn.aphp.fr

33 1 56 01 61 53.

Other Identifiers

DUDLUIV1201EC

Identifier Type: -

Identifier Source: org_study_id