Two thin Percuflex polyurethane stents versus one larger 8Fr silicone stent for malignant ureteral obstruction
Tandem Polyurethane Stents Compared to Single Silicone Stent for Malignant Ureteral Obstruction
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rabin Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Petah Tikva and 1 other locations) |
| Trial ID | NCT05992363 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Petah Tikva and 1 other locations
- Rabin Medical Center — Petah Tikva, Israel (Recruiting)
- Sheba medical center — Ramat Gan, Israel (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.