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

Kidney Calculi Clinical Trial

Official title:

Effect of a Silicone Hydrocoated Double Loop Ureteral Stent on Symptoms and Quality of Life in Patients Undergoing F-URS for Kidney Stone; a Comparative Randomized Multicenter Clinical Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02489656
• Other study ID #: DUDLUIV1201EC
• Status: Recruiting
• Phase: Phase 4
• First received: May 18, 2015
• Last updated: July 1, 2015
• Start date: September 2013
• Est. completion date: December 2016

Study information

• Verified date: May 2015
• Source: Coloplast A/S
• Contact: Pascale HS Holliday, CTM
• Phone: +33 1 40 83 68 58
• Email: frpho[@]coloplast.com
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Calculi

Intervention

Device:
• 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

Locations

Country	Name	City	State
France	Service de Chirurgie Urologique de l'Hôpital Tenon	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Encrustation of double loop ureteral stents	Encrustation of double loop ureteral stents is evaluated by a score of integer values ranging from 0 to 6	after 20 days (JJ stent removal)	No
Primary	USSQ scale (Ureteral Stent Symptoms Questionnaire)		at day 20	No
Secondary	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	No