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

• ClinicalTrials.gov Identifier: NCT00790686
• Recruitment Status: Completed
• First Posted: November 13, 2008
• Last Update Posted: August 21, 2014
• Sponsor: University Hospital, Bordeaux
• Information provided by (Responsible Party): University Hospital, Bordeaux

Tracking Information

• First Submitted Date: November 12, 2008
• First Posted Date: November 13, 2008
• Last Update Posted Date: August 21, 2014
• Study Start Date: November 2008
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 12, 2008): Average durability of the stent MEMOKATH ® 051 [ Time Frame: 3 years ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 17, 2013)

• Proportion of ureteral stent MEMOKATH ® 051 positioning failure [ Time Frame: 3 years ]
• Average quality of life of the patients measured by auto-questionary [ Time Frame: 3 years ]
• Proportion of patients to which the ureteral stent was definitely taken away [ Time Frame: 3 years ]
• Expense of hospitalizations for replacement of the ureteral stent [ Time Frame: 3 years ]
• Proportion of replacement of the ureteral stent [ Time Frame: 3 years ]

Original Secondary Outcome Measures (submitted: November 12, 2008)

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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Tolerance and Effectiveness of Ureteral Stents MEMOKATH ® 051 in Chronic Strictures of the Ureter
• Official Title: Study of Tolerance and Effectiveness of Ureteral Stents MEMOKATH ® 051 in the Treatment of Chronic Strictures of the Ureter

Brief 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.

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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: 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.

Study Arms

Experimental: 1

Memokath 051

Intervention: Procedure: Insertion of Memokath 051

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 30, 2010): 13
• Original Estimated Enrollment (submitted: November 12, 2008): 30
• Actual Study Completion Date: May 2013
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT00790686
• Other Study ID Numbers: CHUBX2008/24
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University Hospital, Bordeaux
• Study Sponsor: University Hospital, Bordeaux
• Collaborators: Not Provided

Investigators

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

• PRS Account: University Hospital, Bordeaux
• Verification Date: August 2014