Tandem Polyurethane Stents Compared to Single Silicone Stent for Malignant Ureteral Obstruction

NCT05992363 | Recruiting DMC FDA Device

• 1 other identifier: 0100-23-RMC
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 2

Brief Summary

Malignant ureteral obstruction (MUO) is an extrinsic ureteral obstruction caused by malignant diseases. This study aim to compare tandem 6 Fr Percuflex™ stents and single large-caliber 8Fr silicone stent in patients with MUO. The primary endpoint is stent failure rate. The secondary endpoints are patient comfort, quality of life and overall survival.

Conditions

Hydronephrosis; Obstruction, Ureter; Renal Failure; Malignancy; Ureter Obstruction; Ureter Stricture

Outcome Measures

Primary Outcomes (1)

• stent failure rate

  Failure will be defined when two of the following three appear: renal colic, rise in serum creatinine, hydronephrosis

  1 year

Secondary Outcomes (2)

• quality of life score

  1 year

• overall survival

  1 year

Study Arms (2)

single silicone stent

ACTIVE COMPARATOR

patients with malignant ureteral obstruction that was treated by single large-caliber 8-12Fr silicone stent

Device: ureteral stent\s insertion

Tandem polyurethane stents

ACTIVE COMPARATOR

patients with malignant ureteral obstruction that was treated by tandem 6 Fr Percuflex™ stents

Device: ureteral stent\s insertion

Interventions

ureteral stent\s insertion DEVICE

ureteral stent\\s insertion in the operating room

Tandem polyurethane stents; single silicone stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient with malignant ureteral obstruction

You may not qualify if:

• ureteral obstruction of other causes
• Language comprehension or other limitation in giving informed consent

Sponsors & Collaborators

• Rabin Medical Center: lead
• Sheba Medical Center: collaborator

Study Sites (2)

Rabin Medical Center

Petah Tikva, 49414, Israel

RECRUITING

Sheba medical center

Ramat Gan, Israel

RECRUITING

MeSH Terms

Conditions

Hydronephrosis; Bites and Stings; Renal Insufficiency; Neoplasms; Ureteral Obstruction

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Ureteral Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urologist

Model Details: RCT

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 15, 2023
• Study Start: December 20, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2)