Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT02489656
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02489656
Study Brief:
Protocol Section:
NCT02489656