An interventional study of ureteral stent\s insertion in Hydronephrosis; Obstruction, Ureter, Renal Failure and Malignancy, sponsored by Rabin Medical Center. Recruiting at 2 sites in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-24.
Sponsored by Rabin Medical Center · Not applicable, Interventional, and Treatment
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.
Malignant ureteral obstruction (MUO) is an extrinsic ureteral obstruction caused by malignant diseases. MUO may induce renal failure, which would be a barrier to several therapies including chemotherapy. Indwelling double-pigtail polymeric ureteral stent is a common method to release renal obstruction, but does not necessarily guarantee renal decompression as most studies reported stent failure with a mean of 30% at a mean time of three months [1-3]. Various endoscopic strategies have been proposed to increase time to failure, including tandem polymeric stents, metallic spiral coil stent, self-expanding Nitinol stent and polymeric stents with different lumen diameter and stiffness [4-7]. However, heterogeneity of MUO, low number of patients, unspecified polymer type, retrospective studies and the lack of a standard method to assess stent failure limit robust comparative analysis.
Tandem ureteral stents (TUS) technique uses two polymeric ureteral stents passed simultaneously to better withstand the presumed compressive forces that overcome conventional single stent. This method offers an additional parallel lumen and allows more extraluminal flow between the two stents [6].
In a study on TUS in 39 renal units with MUO, two 6 Fr stents were inserted. Stent failure, defined by flank pain with increasing creatinine level or worsening hydronephrosis during 3 months after stents insertion, was occurred in 4% of cases [7]. This low failure rate compares favorably with the reported rates with single 6Fr polymeric stent or metallic stent. However, stents irritation, defined by profound lower urinary tract symptoms or renal colic in the absence of worsening hydronephrosis or infection, was reported in 29-85% of patients [7,8].
Silicon stent, which is considered biocompatible and soft, has the potential to be less irritative. In a recent systematic review, silicone stents has less stent-related symptoms in comparison to non-silicone polymers and ''hard'' stents. [9]. However, silicone has high susceptibility to compression, which in case of MUO may results in lower drainage efficacy.
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.
References:
55 studies on the registry are indexed under Hydronephrosis; 9 are open to participants now.
This study's planned enrollment of 106 is close to the median of 100 across 23 interventional studies indexed under Hydronephrosis.
Browse Hydronephrosis studies →Rabin Medical Center is the lead sponsor of 393 studies on the registry; 30 are open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients with malignant ureteral obstruction that was treated by single large-caliber 8-12Fr silicone stent
Device: ureteral stent\s insertion
patients with malignant ureteral obstruction that was treated by tandem 6 Fr Percuflex™ stents
Device: ureteral stent\s insertion
ureteral stent\\s insertion in the operating room
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
quality of life score
using the Ureteral stent symptom questionnaire (USSQ) score
Time frame: 1 year
overall survival
overall survival
Time frame: 1 year
Plan to share: No
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