NCT04250090

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 9, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 31, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

3.1 years

First QC Date

January 17, 2020

Last Update Submit

February 7, 2020

Conditions

Ureter StrictureHydronephrosis

Keywords

Ureter StrictureHydronephrosis

Outcome Measures

Primary Outcomes (4)

  • Hydronephrosis

    no hydronephrosis, mild hydronephrosis, moderate hydronephrosis, severe hydronephrosis

    5 years

  • Renal function

    serum BUN level

    5 years

  • Renal function

    serum Creatine level

    5 years

  • Days of stent placement

    Mean days of stent placement

    5 years

Study Arms (1)

Long-term type ureteral stent set

Patients with Long-term type ureteral stent set due to ureteral stricture.

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The most recent patients who actually used the " Bioteq" Ureteral Stent Set (Long-Term Type) are included, and a non-grouping method is adopted

You may qualify if:

  • Patients who used " Bioteq" Ureteral Stent Set (Long-Term Type) in their treatments.
  • Patients with complete basic parameters.

You may not qualify if:

  • Patients with any of the following conditions are excluded from this clinical study:
  • Patients with incomplete basic parameters.
  • The minorities, children and special populations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

En Chu Kong Hospital

New Taipei City, Sanxia Dist., 23702, Taiwan

RECRUITING

Related Publications (29)

  • Liatsikos EN, Kagadis GC, Barbalias GA, Siablis D. Ureteral metal stents: a tale or a tool? J Endourol. 2005 Oct;19(8):934-9. doi: 10.1089/end.2005.19.934.

    PMID: 16253054RESULT

  • 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: 10.1007/s11604-010-0485-2. Epub 2010 Nov 27.

    PMID: 21113756RESULT

  • 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.

    PMID: 19046096RESULT

  • 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. doi: 10.1007/s00270-007-9031-8. Epub 2007 May 17.

    PMID: 17508243RESULT

  • 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. doi: 10.1007/s00261-007-9233-1.

    PMID: 17440767RESULT

  • Juaneda B, Alcaraz A, Bujons A, Guirado L, Diaz JM, Marti J, de la Torre P, Sabate S, Villavicencio H. Endourological management is better in early-onset ureteral stenosis in kidney transplantation. Transplant Proc. 2005 Nov;37(9):3825-7. doi: 10.1016/j.transproceed.2005.09.199.

    PMID: 16386552RESULT

  • 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. doi: 10.1590/s1677-55382005000300013.

    PMID: 15992432RESULT

  • Uthappa MC, Cowan NC. Retrograde or antegrade double-pigtail stent placement for malignant ureteric obstruction? Clin Radiol. 2005 May;60(5):608-12. doi: 10.1016/j.crad.2004.11.014.

    PMID: 15851050RESULT

  • Unsal A, Cimentepe E, Balbay MD. Routine ureteral dilatation is not necessary for ureteroscopy. Int Urol Nephrol. 2004;36(4):503-6. doi: 10.1007/s11255-004-0860-y.

    PMID: 15787325RESULT

  • Mattei A, Danuser H. [Stents in urology]. Ther Umsch. 2003 Apr;60(4):233-7. doi: 10.1024/0040-5930.60.4.233. German.

    PMID: 12731434RESULT

  • 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. doi: 10.1016/s0302-2838(02)00281-6.

    PMID: 12234513RESULT

  • 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. doi: 10.1046/j.1442-2042.2001.00393.x.

    PMID: 11851764RESULT

  • 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. doi: 10.1159/000052506.

    PMID: 11464040RESULT

  • 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. doi: 10.1097/00005392-199909010-00017.

    PMID: 10458345RESULT

  • 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. doi: 10.1159/000019926.

    PMID: 10364655RESULT

  • 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. doi: 10.1089/end.1998.12.335.

    PMID: 9726399RESULT

  • 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. doi: 10.1016/S0022-5347(17)63130-6. No abstract available.

    PMID: 6025928RESULT

  • 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. doi: 10.1046/j.1464-410x.1998.00543.x-i1.

    PMID: 10691815RESULT

  • 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. doi: 10.1111/j.1464-410x.1986.tb05900.x.

    PMID: 3801820RESULT

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

    PMID: 3043868RESULT

  • 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.

    PMID: 20811552RESULT

  • Lam JS, Gupta M. Tips and tricks for the management of retained ureteral stents. J Endourol. 2002 Dec;16(10):733-41. doi: 10.1089/08927790260472881.

    PMID: 12542876RESULT

  • 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. doi: 10.1097/00005392-200009010-00007.

    PMID: 10953117RESULT

  • 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. doi: 10.1089/end.1999.13.377.

    PMID: 10446801RESULT

  • Schulze KA, Wettlaufer JN, Oldani G. Encrustation and stone formation: complication of indwelling ureteral stents. Urology. 1985 Jun;25(6):616-9. doi: 10.1016/0090-4295(85)90293-6.

    PMID: 4012953RESULT

  • 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. doi: 10.1016/s0022-5347(17)38146-6.

    PMID: 1942324RESULT

  • Somers WJ. Management of forgotten or retained indwelling ureteral stents. Urology. 1996 Mar;47(3):431-5. doi: 10.1016/S0090-4295(99)80468-3.

    PMID: 8633417RESULT

  • 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. doi: 10.1016/s0090-4295(01)01317-6.

    PMID: 11597531RESULT

  • 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. doi: 10.1016/S1607-551X(09)70324-9.

    PMID: 16849106RESULT

MeSH Terms

Conditions

Hydronephrosis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Chung Cheng Wang, MD. Ph. D

    Deputy Superintendent of Department of Education and Research

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chung Cheng Wang, MD. Ph. D

CONTACT

886-226723456ericwcc@ms27.hinet.net

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of urology

Study Record Dates

First Submitted

January 17, 2020

First Posted

January 31, 2020

Study Start

July 9, 2019

Primary Completion

July 30, 2022

Study Completion

October 31, 2022

Last Updated

February 11, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)