Health TrialsbyHealthPanel

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

ConditionsHydronephrosis; Obstruction, UreterRenal FailureMalignancyUreter ObstructionUreter Stricture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRabin Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patient with malignant ureteral obstruction

Disqualifiers

ureteral obstruction of other causes

Language comprehension or other limitation in giving informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • ureteral stent\s insertion

    Device

    ureteral stent\\s insertion in the operating room

Treatment groups

106 Participants
are divided into 2 treatment groups
Group A: single silicone stentActive comparator 1 intervention
Group B: Tandem polyurethane stentsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

stent failure rate

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

Time frame
1 year

Secondary outcomes

1

quality of life score

using the Ureteral stent symptom questionnaire (USSQ) score

Time frame
1 year
2

overall survival

overall survival

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rabin Medical Center

Lead sponsor

Sheba Medical Center

Collaborator

Source ClinicalTrials.gov
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