Two thin Percuflex polyurethane stents versus one larger 8Fr silicone stent for malignant ureteral obstruction
Official title: Tandem Polyurethane Stents Compared to Single Silicone Stent for Malignant Ureteral Obstruction
Run by Rabin Medical Center · NCT05992363 · Data updated 2026-11-12
The trial will try placing two 6Fr Percuflex polyurethane stents side-by-side versus a single large 8Fr silicone stent in people with malignant ureteral obstruction to see which approach fails less often and how they affect comfort, quality of life, and survival.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 106 (estimated) |
| Sponsor | Rabin Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Petah Tikva and 1 other locations) |
| Status | Recruiting |
| Started | December 20, 2023 |
| Main results expected | December 2026 |
| Study ends | December 2027 |
| Registry record updated | July 24, 2025 |
| Trial ID | NCT05992363 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with malignant ureteral obstruction causing hydronephrosis who can give informed consent and are suitable for endoscopic stent placement are the intended participants.
✕Probably not a fit
Patients with non-malignant causes of ureteral obstruction, those unable to tolerate stent placement, or those who cannot provide informed consent are not likely to benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Patients with malignant ureteral obstruction will undergo placement of either tandem 6Fr Percuflex polymeric ureteral stents or a single large-caliber 8Fr silicone stent, with clinical follow-up to detect stent failure. The primary outcome is the stent failure rate, defined by symptoms, rising creatinine, or worsening hydronephrosis; secondary outcomes include patient comfort, quality of life, and overall survival. The protocol compares the two endoscopic strategies prospectively at two Israeli tertiary centers to determine which maintains ureteral drainage longer. Data collection will include imaging, laboratory renal function, and patient-reported measures over follow-up visits.
Why it matters
Potential benefit: If successful, the tandem stent approach could reduce stent failures, lower the risk of renal deterioration, and decrease the need for repeat procedures.
How similar studies have gone: Small retrospective series have reported low failure rates with tandem stents (for example, a 39-unit series with about 4% failure), but robust randomized or large prospective data are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * patient with malignant ureteral obstruction Exclusion Criteria: * ureteral obstruction of other causes * Language comprehension or other limitation in giving informed consent
Where it's running
-
Rabin Medical Center
Petah Tikva, Israel Recruiting -
Sheba medical center
Ramat Gan, Israel Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.