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

• Sponsor: Rabin Medical Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05992363
• Collaborator: Sheba Medical Center (Other)
• Enrollment: 106
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 38
• Patients Per Site: 53
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hydronephrosis; Obstruction, Ureter; Renal Failure; Malignancy; Ureter Obstruction; Ureter Stricture	Device: ureteral stent\s insertion	Phase 3

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 106 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Tandem Polyurethane Stents Compared to Single Silicone Stent for Malignant Ureteral Obstruction
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2025
• Anticipated Study Completion Date: Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: single silicone stent patients with malignant ureteral obstruction that was treated by single large-caliber 8-12Fr silicone stent	Device: ureteral stent\s insertion; ureteral stent\s insertion in the operating room
Active Comparator: Tandem polyurethane stents 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

Outcome Measures

Primary Outcome Measures

1. stent failure rate [1 year]

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

Secondary Outcome Measures

1. quality of life [1 year]

   using the Ureteral stent symptom questionnaire (USSQ) score

2. overall survival [1 year]

   overall survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patient with malignant ureteral obstruction

Exclusion Criteria:

• ureteral obstruction of other causes

• Language comprehension or other limitation in giving informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rabin Medical Center	Petah Tikva		Israel	49414
2	Sheba medical center	Ramat Gan		Israel

Sponsors and Collaborators

• Rabin Medical Center
• Sheba Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael Frumer, Urologist, Rabin Medical Center
• ClinicalTrials.gov Identifier: NCT05992363
• Other Study ID Numbers: 0100-23-RMC
• First Posted: Aug 15, 2023
• Last Update Posted: Aug 15, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hydronephrosis; Ureteral Obstruction

Study Results

No Results Posted as of Aug 15, 2023