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

Ureteral Obstruction Clinical Trial

— TOTEME  

Official title:

Study of Tolerance and Effectiveness of Ureteral Stents MEMOKATH ® 051 in the Treatment of Chronic Strictures of the Ureter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00790686
• Other study ID #: CHUBX2008/24
• Status: Completed
• Phase: Phase 2
• First received: November 12, 2008
• Last updated: August 20, 2014
• Start date: November 2008
• Est. completion date: May 2013

Study information

• Verified date: August 2014
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ureteral Obstruction

Intervention

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.

Locations

Country	Name	City	State
France	Department of Urology, University Hospital, Bordeaux	Bordeaux
France	Department of Urology, University Hospital, Limoges	Limoges
France	Department of Urology, Hospices Civils de Lyon	Lyon
France	Department of Urology, University Hospital, Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Klarskov P, Nordling J, Nielsen JB. Experience with Memokath 051 ureteral stent. Scand J Urol Nephrol. 2005;39(2):169-72. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Poulsen AL, Schou J, Ovesen H, Nordling J. Memokath: a second generation of intraprostatic spirals. Br J Urol. 1993 Sep;72(3):331-4. — View Citation

Ringel A, Richter S, Shalev M, Nissenkorn I. Late complications of ureteral stents. Eur Urol. 2000 Jul;38(1):41-4. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average durability of the stent MEMOKATH ® 051		3 years	Yes
Secondary	Proportion of ureteral stent MEMOKATH ® 051 positioning failure		3 years	Yes
Secondary	Average quality of life of the patients measured by auto-questionary		3 years	Yes
Secondary	Proportion of patients to which the ureteral stent was definitely taken away		3 years	Yes
Secondary	Expense of hospitalizations for replacement of the ureteral stent		3 years	Yes
Secondary	Proportion of replacement of the ureteral stent		3 years	Yes