Tolerance and Effectiveness of Ureteral Stents MEMOKATH ® 051 in Chronic Strictures of the Ureter - Full Text View

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 2


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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 positioning failure [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Average quality of life of the patients measured by auto-questionary [ 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 ]


Enrollment:	13
Study Start Date:	November 2008
Study Completion Date:	May 2013
Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 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 lumbar 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 stenosis of the ureter treated by placement of a ureteral endoprosthesis for more than six months;
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
Lithiasic inlay probe Double J with obstruction within 6 months
Persons put under maintenance of justice
Persons in inability to understand the sequence of try

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790686

Locations


France
Department of Urology, University Hospital, Bordeaux
Bordeaux, France, 22076
Department of Urology, University Hospital, Limoges
Limoges, France, 87042
Department of Urology, Hospices Civils de Lyon
Lyon, France, 69437
Department of Urology, University Hospital, Toulouse
Toulouse, France, 31059

Sponsors and Collaborators

University Hospital, Bordeaux

Investigators


Principal Investigator:	Gregoire Robert, MD	University Hospital, Bordeaux
Study Chair:	Antoine BENARD, 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.

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
ClinicalTrials.gov Identifier:	NCT00790686 History of Changes
Other Study ID Numbers:	CHUBX2008/24
Study First Received:	November 12, 2008
Last Updated:	August 20, 2014
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:


Ureteral obstruction Urologic surgical procedure Stents Endoscopy Urology

Additional relevant MeSH terms:


Ureteral Obstruction Ureteral Diseases Urologic Diseases

ClinicalTrials.gov processed this record on February 27, 2015

Tolerance and Effectiveness of Ureteral Stents MEMOKATH ® 051 in Chronic Strictures of the Ureter (TOTEME)