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

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ClinicalTrials.gov Identifier: NCT05992363
Recruitment Status : Not yet recruiting
First Posted : August 15, 2023
Last Update Posted : August 15, 2023
Sponsor:
Collaborator:
Sheba Medical Center
Information provided by (Responsible Party):
Michael Frumer, Rabin Medical Center

Tracking Information
First Submitted Date  ICMJE August 8, 2023
First Posted Date  ICMJE August 15, 2023
Last Update Posted Date August 15, 2023
Estimated Study Start Date  ICMJE October 2023
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2023)		 stent failure rate [ Time Frame: 1 year ]
Failure will be defined when two of the following three appear: renal colic, rise in serum creatinine, hydronephrosis
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2023)
  • quality of life [ Time Frame: 1 year ]
    using the Ureteral stent symptom questionnaire (USSQ) score
  • overall survival [ Time Frame: 1 year ]
    overall survival
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tandem Polyurethane Stents Compared to Single Silicone Stent for Malignant Ureteral Obstruction
Official Title  ICMJE Tandem Polyurethane Stents Compared to Single Silicone Stent for Malignant Ureteral Obstruction
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.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hydronephrosis; Obstruction, Ureter
  • Renal Failure
  • Malignancy
  • Ureter Obstruction
  • Ureter Stricture
Intervention  ICMJE Device: ureteral stent\s insertion
ureteral stent\s insertion in the operating room
Study Arms  ICMJE
  • Active Comparator: single silicone stent
    patients with malignant ureteral obstruction that was treated by single large-caliber 8-12Fr silicone stent
    Intervention: Device: ureteral stent\s insertion
  • Active Comparator: Tandem polyurethane stents
    patients with malignant ureteral obstruction that was treated by tandem 6 Fr Percuflex™ stents
    Intervention: Device: ureteral stent\s insertion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 8, 2023)		 106
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2026
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patient with malignant ureteral obstruction

Exclusion Criteria:

  • ureteral obstruction of other causes
  • Language comprehension or other limitation in giving informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05992363
Other Study ID Numbers  ICMJE 0100-23-RMC
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Michael Frumer, Rabin Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Rabin Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Sheba Medical Center
Investigators  ICMJE Not Provided
PRS Account Rabin Medical Center
Verification Date August 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP