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Tolerance and Effectiveness of Ureteral Stents MEMOKATH ® 051 in Chronic Strictures of the Ureter (TOTEME)
This study is not yet open for participant recruitment.
Verified by University Hospital, Bordeaux, November 2008
First Received: November 12, 2008   No Changes Posted
Sponsored by: University Hospital, Bordeaux
Information provided by: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00790686
  Purpose

TOTEME offers to treat certain chronic strictures of the ureter with MEMOKATH 051 to assess its effectiveness, tolerance and mean durability during a 3 years follow up period. Patients usually treated with double J stents will be included. The double J stent will be replaced by a MEMOKATH 051 stent under general anesthesia during a cystoscopy. After this procedure, the patients will have medical examinations, blood exams, radiography and renal sonography during 3 years. If a problem of tolerance or effectiveness is diagnosed, the ureteral stent MEMOKATH 051 will be changed or replaced with a double J stent.


Condition Intervention Phase
Ureteral Obstruction
Procedure: Insertion of Memokath 051
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Study of Tolerance and Effectiveness of Ureteral Stents MEMOKATH ® 051 in the Treatment of Chronic Strictures of the Ureter

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Average durability of the stent MEMOKATH ® 051 [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of ureteral stent MEMOKATH ® 051 positionning failure [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Average quality of life of the patients measured by the ladder SF12 [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Proportion of patients to which the ureteral stent was definitely taken away [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Expense of hospitalizations for replacement of the ureteral stent [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Proportion of replacement of the ureteral stent [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: November 2008
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Memokath 051
Procedure: Insertion of Memokath 051
Patients usually treated with double J stents will be included. The double J stent will be replaced by a MEMOKATH 051 stent under general anesthesia during a cystoscopy.

Detailed Description:

Introduction:

The chronic strictures of the ureter are usually treated by double J stents. They allow the emptying of the kidney and avoid the deterioration of renal function. Unfortunately, double J stents have to be replaced every 6 month and are at the origin of irritative lower urinary tract symptoms and lumbar pain which corrupt the quality of life of the patients. Ureteral stricture could also be treated with MEMOKATH 051. These new ureteral stents seem not to require iterative changes and also not to cause irritative symptoms and lombar pain. MEMOKATH 051 could therefore allow to reduce the number of changes and to ameliorate the quality of life of the patients.

Main objective:

Main objective is to assess effectiveness and tolerance of the MEMOKATH ® 051 in the treatment of chronic strictures of the ureter.

Resume:

Patients usually treated with double J stents will be included. The double J stent will be replaced by a MEMOKATH 051 stent under general anesthesia during a cystoscopy. After this procedure, the patients will have medical examination, blood exams, radiography and renal sonography at 1 month, 3 month and every 6 month during a 3 years follow up period. If a problem of tolerance or effectiveness is diagnosed, the ureteral stent MEMOKATH 051 will be changed or replaced with a double J stent and an adverse event will be declared.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-year-old or superior
  • Chronic Stricture of the ureter treated double J stent for more than 1 year
  • No possibility for surgical or endoscopic treatment of the ureteral stricture
  • Free Consent, dated and signed by the patient
  • Affiliated Subject of a regime of French national health and pensions organization.

Exclusion Criteria:

  • Age under 18 year old
  • Pregnant or nursing Women
  • Patient having a life expectancy of less than 1 year
  • Patient having unique kidney
  • Patient having severe renal insufficiency (creatinin clearance under 30 ml/min)
  • Possible surgical or endoscopic treatment of ureteral stricture
  • Repeated urinary tract stones
  • Urothelial tumor of the bladder
  • Retro peritoneal fibrosis in the course of evolution
  • Complications of double J stents requiring more thanks a lot every 6 months
  • Against anaesthetic indication
  • Persons put under maintenance of justice
  • Persons in inability to understand the sequence of try
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00790686

Contacts
Contact: Gregoire Robert, MD +33 5 56 79 55 35 gregoire.robert@chu-bordeaux.fr

Locations
France
Department of Urology, University Hospital, Bordeaux
Bordeaux, France, 22076
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Gregoire Robert, MD University Hospital, Bordeaux
  More Information

Publications:
Kulkarni R, Bellamy E. Nickel-titanium shape memory alloy Memokath 051 ureteral stent for managing long-term ureteral obstruction: 4-year experience. J Urol. 2001 Nov;166(5):1750-4.
Klarskov P, Nordling J, Nielsen JB. Experience with Memokath 051 ureteral stent. Scand J Urol Nephrol. 2005;39(2):169-72.
Pariente JL, Conort P. [Biomaterials used in contact with the urinary tract for urine drainage: catheters and ureteric stents] Prog Urol. 2005 Nov;15(5):897-906. Review. French. No abstract available.
Ringel A, Richter S, Shalev M, Nissenkorn I. Late complications of ureteral stents. Eur Urol. 2000 Jul;38(1):41-4.
Kehinde EO, Rotimi VO, Al-Awadi KA, Abdul-Halim H, Boland F, Al-Hunayan A, Pazhoor A. Factors predisposing to urinary tract infection after J ureteral stent insertion. J Urol. 2002 Mar;167(3):1334-7.
Al-Kandari AM, Al-Shaiji TF, Shaaban H, Ibrahim HM, Elshebiny YH, Shokeir AA. Effects of proximal and distal ends of double-J ureteral stent position on postprocedural symptoms and quality of life: a randomized clinical trial. J Endourol. 2007 Jul;21(7):698-702.
Hübner WA, Plas EG, Stoller ML. The double-J ureteral stent: in vivo and in vitro flow studies. J Urol. 1992 Aug;148(2 Pt 1):278-80.
Poulsen AL, Schou J, Ovesen H, Nordling J. Memokath: a second generation of intraprostatic spirals. Br J Urol. 1993 Sep;72(3):331-4.
Laaksovirta S, Välimaa T, Isotalo T, Törmälä P, Talja M, Tammela TL. Encrustation and strength retention properties of the self-expandable, biodegradable, self-reinforced L-lactide-glycolic acid co-polymer 80:20 spiral urethral stent in vitro. J Urol. 2003 Aug;170(2 Pt 1):468-71.
Vaidyanathan S, Soni BM, Oo T, Sett P, Hughes PL, Singh G. Long-term result of Memokath urethral sphincter stent in spinal cord injury patients. BMC Urol. 2002 Nov 11;2:12. Epub 2002 Nov 11.
Perry MJ, Roodhouse AJ, Gidlow AB, Spicer TG, Ellis BW. Thermo-expandable intraprostatic stents in bladder outlet obstruction: an 8-year study. BJU Int. 2002 Aug;90(3):216-23.
Arya M, Mostafid H, Patel HR, Kellett MJ, Philp T. The self-expanding metallic ureteric stent in the long-term management of benign ureteric strictures. BJU Int. 2001 Sep;88(4):339-42.

Responsible Party: University Hospital, Bordeaux ( Jean-Pierren LEROY / Clinical Research and Innovation Director )
Study ID Numbers: CHUBX2008/24
Study First Received: November 12, 2008
Last Updated: November 12, 2008
ClinicalTrials.gov Identifier: NCT00790686     History of Changes
Health Authority: France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Bordeaux:
Ureteral obstruction
Urologic surgical procedure
Stents
Endoscopy
Urology

Study placed in the following topic categories:
Urologic Diseases
Ureteral Obstruction
Anesthetics
Ureteral Diseases
Constriction, Pathologic

Additional relevant MeSH terms:
Urologic Diseases
Ureteral Obstruction
Ureteral Diseases

ClinicalTrials.gov processed this record on September 10, 2009