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Hydronephrosis; Obstruction, UreterTSTENTNCT05992363

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

A study testing ureteral stent\s insertion in people with Hydronephrosis; Obstruction, Ureter and Renal Failure, run by Rabin Medical Center at 2 sites in Israel.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ureteral stent\s insertion
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
2 sitesIsrael
Study dates
20 Dec 2023to Dec 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patient with malignant ureteral obstruction

Who cannot join

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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Israel2 sites, 2 recruiting
  • Rabin Medical Center

    Petah Tikva, 49414

    Michael Frumer, MD, +972542686959, mic1039@gmail.com

    Recruiting
  • Sheba medical center

    Ramat Gan

    Ari Luder, MD, +972527812580, ariluder@yahoo.com

    Recruiting

Other trials in Israel

About this study

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.

Read the detailed description

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:

  1. Docimo SG, Dewolf WC. High failure rate of indwelling ureteral stents in patients with extrinsic obstruction: experience at 2 institutions. J Urol. 1989;142(2 Pt 1):277-279. doi:10.1016/s0022-5347(17)38729-3
  2. Vogt B, Blanchet LH. Analysis of Ureteral Tumour Stents for Malignant Ureteral Obstruction: Towards Reshaping an Optimal Stent. Res Rep Urol. 2021;13:773-782. Published 2021 Oct 27. doi:10.2147/RRU.S334277
  3. Chung SY, Stein RJ, Landsittel D, et al. 15-year experience with the management of extrinsic ureteral obstruction with indwelling ureteral stents. J Urol. 2004;172(2):592-595. doi:10.1097/01.ju.0000130510.28768.f5
  4. Patel C, Loughran D, Jones R, Abdulmajed M, Shergill I. The resonance® metallic ureteric stent in the treatment of chronic ureteric obstruction: a safety and efficacy analysis from a contemporary clinical series. BMC Urol. 2017;17(1):16. Published 2017 Mar 10. doi:10.1186/s12894-017-0204-8
  5. Khoo CC, Ho C, Palaniappan V, et al. Single-Center Experience with Three Metallic Ureteral Stents (Allium® URS, Memokath™-051, and Resonance®) for Chronic Ureteral Obstruction. J Endourol. 2021;35(12):1829-1837. doi:10.1089/end.2021.0208
  6. Fromer DL, Shabsigh A, Benson MC, Gupta M. Simultaneous multiple double pigtail stents for malignant ureteral obstruction. Urology. 2002;59(4):594-596. doi:10.1016/s0090-4295(01)01646-7
  7. Elsamra SE, Motato H, Moreira DM, et al. Tandem ureteral stents for the decompression of malignant and benign obstructive uropathy. J Endourol. 2013;27(10):1297-1302. doi:10.1089/end.2013.0281
  8. Shvero A, Haifler M, Mahmud H, Dotan Z, Winkler H, Kleinmann N. Quality of life with tandem ureteral stents compared to percutaneous nephrostomy for malignant ureteral obstruction. Support Care Cancer. 2022;30(11):9541-9548. doi:10.1007/s00520-022-07354-2
  9. Boeykens M, Keller EX, Bosio A, et al. Impact of Ureteral Stent Material on Stent-related Symptoms: A Systematic Review of the Literature. Eur Urol Open Sci. 2022;45:108-117. Published 2022 Oct 19. doi:10.1016/j.euros.2022.09.005
Being tested
ureteral stent\s insertion
Medical subject headings
Hydronephrosis, Bites and Stings, Renal Insufficiency, Neoplasms, Ureteral Obstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ureteral stent\s insertionDevice

    ureteral stent\s insertion in the operating room

Study groups in NCT05992363
Study groupRoleWhat they receive
single silicone stentActive comparatorpatients with malignant ureteral obstruction that was treated by single large-caliber 8-12Fr silicone stent
Receives: Device: ureteral stent\s insertion
Tandem polyurethane stentsActive comparatorpatients with malignant ureteral obstruction that was treated by tandem 6 Fr Percuflex™ stents
Receives: Device: ureteral stent\s insertion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. stent failure rate

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

    Measured: 1 year

Secondary outcomes (2)
  1. quality of life score

    using the Ureteral stent symptom questionnaire (USSQ) score

    Measured: 1 year

  2. overall survival

    overall survival

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2023
  2. Study start20 Dec 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
RCT
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
106 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05992363
Sponsor's protocol ID
0100-23-RMC
Acronym
TSTENT
Status last verified
Jul 2025
First submitted
8 Aug 2023
Last updated
24 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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