Post-Marketing Follow-Up of Long-term Type Ureteral Stent Set

Hydronephrosis Clinical Trial

Official title:

Post-Marketing Follow-Up of Long-term Type Ureteral Stent Set

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04250090
• Other study ID #: ECKIRB1050505
• Status: Recruiting
• Start date: July 9, 2019
• Est. completion date: October 31, 2022

Study information

• Verified date: February 2020
• Source: En Chu Kong Hospital
• Contact: Chung Cheng Wang, MD. Ph. D
• Phone: 886-226723456
• Email: ericwcc[@]ms27.hinet.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Ureteral stents have been widely used in many urological operations. Although there are several reports regarding the effectiveness of long-term ureteral stents for malignancy ureteral obstruction, ureteral stricture and urolithiasis, the experience is limited about the long-term ureteral stents made by Taiwan. The investigators have to propose the 5-year post-market survey report. Though this observation study, The investigators can further understand the clinical safety and effectiveness of placing ureteral stents

Description:

Ureteral stents have been widely used in many urological operations. The main purposes of placing ureteral stents include improvement of ureteral obstruction, protecting renal function and drainage of infection. Although there are several reports regarding the effectiveness of long-term ureteral stents for malignancy ureteral obstruction, ureteral stricture and urolithiasis, the experience is limited about the long-term ureteral stents made by Taiwan. Thus, The investigators will conduct this post-marketing survey to observe and investigate the changes of ureteral stents, e.g. hydronephrosis, infection and stone formation. Now this product has been approved by European Medical Device Administration. The investigators have to propose the 5-year post-market survey report. Though this observation study, The investigators can further understand the clinical safety and effectiveness of placing ureteral stents

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 31, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Patients who used " Bioteq" Ureteral Stent Set (Long-Term Type) in their treatments.

2. Patients with complete basic parameters.

Exclusion Criteria:

1. Patients with any of the following conditions are excluded from this clinical study:

Patients with incomplete basic parameters.

2. The minorities, children and special populations

Related Conditions & MeSH terms

• Constriction, Pathologic
• Hydronephrosis
• Ureter Stricture

Locations

Country	Name	City	State
Taiwan	En Chu Kong Hospital	New Taipei City	Sanxia Dist.

Sponsors (1)

Lead Sponsor	Collaborator
En Chu Kong Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (29)

Ahallal Y, Khallouk A, El Fassi MJ, Farih MH. Risk factor analysis and management of ureteral double-j stent complications. Rev Urol. 2010 Spring;12(2-3):e147-51. — View Citation

Aytekin C, Boyvat F, Harman A, Ozyer U, Colak T, Haberal M. Percutaneous therapy of ureteral obstructions and leak after renal transplantation: long-term results. Cardiovasc Intervent Radiol. 2007 Nov-Dec;30(6):1178-84. Epub 2007 May 17. — View Citation

Bach T, Geavlete B, Herrmann TW, Gross AJ. Retrograde blind endoureterotomy for subtotal ureteral strictures: a new technique. J Endourol. 2008 Nov;22(11):2565-70. doi: 10.1089/end.2008.0173. — View Citation

Barbalias GA, Liatsikos EN, Kalogeropoulou C, Karnabatidis D, Zabakis P, Athanasopoulos A, Perimenis P, Siablis D. Externally coated ureteral metallic stents: an unfavorable clinical experience. Eur Urol. 2002 Sep;42(3):276-80. — View Citation

Borboroglu PG, Kane CJ. Current management of severely encrusted ureteral stents with a large associated stone burden. J Urol. 2000 Sep;164(3 Pt 1):648-50. — View Citation

Egilmez T, Guvel S, Kilinc F, Yaycioglu O, Ozkardes H. Management of complete ureteral obstructions with a transluminal puncture technique. Int Braz J Urol. 2005 May-Jun;31(3):264-8. — View Citation

el-Faqih SR, Shamsuddin AB, Chakrabarti A, Atassi R, Kardar AH, Osman MK, Husain I. Polyurethane internal ureteral stents in treatment of stone patients: morbidity related to indwelling times. J Urol. 1991 Dec;146(6):1487-91. — View Citation

Hibi H, Kato K, Mitsui K, Taki T, Yamada Y, Honda N, Fukatsu H. Endoscopic ureteral incision using the holmium:YAG laser. Int J Urol. 2001 Dec;8(12):657-61. — View Citation

Juaneda B, Alcaraz A, Bujons A, Guirado L, Díaz JM, Martí J, de la Torre P, Sabaté S, Villavicencio H. Endourological management is better in early-onset ureteral stenosis in kidney transplantation. Transplant Proc. 2005 Nov;37(9):3825-7. — View Citation

Kilciler M, Erdemir F, Bedir S, Coban H, Erten K, Guven O, Topac H. Spontaneous ureteral stent fragmentation: a case report and review of the literature. Kaohsiung J Med Sci. 2006 Jul;22(7):363-6. — View Citation

Kim BM, Park SI. Placement of double-J ureteric stent using the pull-through technique in patients with tight ureteric stenosis. Abdom Imaging. 2008 Mar-Apr;33(2):237-40. — View Citation

Lam JS, Gupta M. Tips and tricks for the management of retained ureteral stents. J Endourol. 2002 Dec;16(10):733-41. — View Citation

Liatsikos EN, Kagadis GC, Barbalias GA, Siablis D. Ureteral metal stents: a tale or a tool? J Endourol. 2005 Oct;19(8):934-9. Review. — View Citation

Lin DW, Bush WH, Mayo ME. Endourological treatment of ureteroenteric strictures: efficacy of Acucise endoureterotomy. J Urol. 1999 Sep;162(3 Pt 1):696-8. Review. — View Citation

Mattei A, Danuser H. [Stents in urology]. Ther Umsch. 2003 Apr;60(4):233-7. German. — View Citation

Micali S, De Carli P, Miano R, O'Sullivan D, Lamanna L, Micali F. Double-J ureteral stents: an alternative to external urinary stents in orthotopic bladder substitution. Eur Urol. 2001 May;39(5):575-9. — View Citation

Mohan-Pillai K, Keeley FX Jr, Moussa SA, Smith G, Tolley DA. Endourological management of severely encrusted ureteral stents. J Endourol. 1999 Jun;13(5):377-9. — View Citation

Pocock RD, Stower MJ, Ferro MA, Smith PJ, Gingell JC. Double J stents. A review of 100 patients. Br J Urol. 1986 Dec;58(6):629-33. — View Citation

Puppo P, Ricciotti G, Bozzo W, Introini C. Primary endoscopic treatment of ureteric calculi. A review of 378 cases. Eur Urol. 1999;36(1):48-52. — View Citation

Ravery V, de la Taille A, Hoffmann P, Moulinier F, Hermieu JF, Delmas V, Boccon-Gibod L. Balloon catheter dilatation in the treatment of ureteral and ureteroenteric stricture. J Endourol. 1998 Aug;12(4):335-40. — View Citation

Richter S, Ringel A, Shalev M, Nissenkorn I. The indwelling ureteric stent: a 'friendly' procedure with unfriendly high morbidity. BJU Int. 2000 Mar;85(4):408-11. — View Citation

Saltzman B. Ureteral stents. Indications, variations, and complications. Urol Clin North Am. 1988 Aug;15(3):481-91. Review. — View Citation

Schulze KA, Wettlaufer JN, Oldani G. Encrustation and stone formation: complication of indwelling ureteral stents. Urology. 1985 Jun;25(6):616-9. — View Citation

Singh I, Gupta NP, Hemal AK, Aron M, Seth A, Dogra PN. Severely encrusted polyurethane ureteral stents: management and analysis of potential risk factors. Urology. 2001 Oct;58(4):526-31. — View Citation

Somers WJ. Management of forgotten or retained indwelling ureteral stents. Urology. 1996 Mar;47(3):431-5. — View Citation

Unsal A, Cimentepe E, Balbay MD. Routine ureteral dilatation is not necessary for ureteroscopy. Int Urol Nephrol. 2004;36(4):503-6. — View Citation

Uthappa MC, Cowan NC. Retrograde or antegrade double-pigtail stent placement for malignant ureteric obstruction? Clin Radiol. 2005 May;60(5):608-12. — View Citation

Zeljko M, Markovic B, Mladenovic A, Mijailovic M, Lukic S. Balloon dilatation and insertion of temporary coated stents using a retrograde approach in patients with irreversible strictures of the distal ureter. Jpn J Radiol. 2010 Nov;28(9):695-9. doi: 10.1 — View Citation

Zimskind PD, Fetter TR, Wilkerson JL. Clinical use of long-term indwelling silicone rubber ureteral splints inserted cystoscopically. J Urol. 1967 May;97(5):840-4. — View Citation

* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hydronephrosis	no hydronephrosis, mild hydronephrosis, moderate hydronephrosis, severe hydronephrosis	5 years
Primary	Renal function	serum BUN level	5 years
Primary	Renal function	serum Creatine level	5 years
Primary	Days of stent placement	Mean days of stent placement	5 years