Tolerance and Effectiveness of Ureteral Stents MEMOKATH ® 051 in Chronic Strictures of the Ureter (TOTEME)
Primary Purpose
Ureteral Obstruction
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Insertion of Memokath 051
Sponsored by
About this trial
This is an interventional treatment trial for Ureteral Obstruction focused on measuring Ureteral obstruction, Urologic surgical procedure, Stents, Endoscopy, Urology
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
Sites / Locations
- Department of Urology, University Hospital, Bordeaux
- Department of Urology, University Hospital, Limoges
- Department of Urology, Hospices Civils de Lyon
- Department of Urology, University Hospital, Toulouse
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Memokath 051
Outcomes
Primary Outcome Measures
Average durability of the stent MEMOKATH ® 051
Secondary Outcome Measures
Proportion of ureteral stent MEMOKATH ® 051 positioning failure
Average quality of life of the patients measured by auto-questionary
Proportion of patients to which the ureteral stent was definitely taken away
Expense of hospitalizations for replacement of the ureteral stent
Proportion of replacement of the ureteral stent
Full Information
NCT ID
NCT00790686
First Posted
November 12, 2008
Last Updated
August 20, 2014
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT00790686
Brief Title
Tolerance and Effectiveness of Ureteral Stents MEMOKATH ® 051 in Chronic Strictures of the Ureter
Acronym
TOTEME
Official Title
Study of Tolerance and Effectiveness of Ureteral Stents MEMOKATH ® 051 in the Treatment of Chronic Strictures of the Ureter
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureteral Obstruction
Keywords
Ureteral obstruction, Urologic surgical procedure, Stents, Endoscopy, Urology
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Memokath 051
Intervention Type
Procedure
Intervention Name(s)
Insertion of Memokath 051
Intervention Description
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.
Primary Outcome Measure Information:
Title
Average durability of the stent MEMOKATH ® 051
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Proportion of ureteral stent MEMOKATH ® 051 positioning failure
Time Frame
3 years
Title
Average quality of life of the patients measured by auto-questionary
Time Frame
3 years
Title
Proportion of patients to which the ureteral stent was definitely taken away
Time Frame
3 years
Title
Expense of hospitalizations for replacement of the ureteral stent
Time Frame
3 years
Title
Proportion of replacement of the ureteral stent
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregoire Robert, MD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antoine BENARD, MD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Urology, University Hospital, Bordeaux
City
Bordeaux
ZIP/Postal Code
22076
Country
France
Facility Name
Department of Urology, University Hospital, Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Department of Urology, Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Department of Urology, University Hospital, Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
11586216
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.
Results Reference
background
PubMed Identifier
16019773
Citation
Klarskov P, Nordling J, Nielsen JB. Experience with Memokath 051 ureteral stent. Scand J Urol Nephrol. 2005;39(2):169-72. doi: 10.1080/00365590510007720.
Results Reference
background
PubMed Identifier
16475655
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. No abstract available. French.
Results Reference
background
PubMed Identifier
10859440
Citation
Ringel A, Richter S, Shalev M, Nissenkorn I. Late complications of ureteral stents. Eur Urol. 2000 Jul;38(1):41-4. doi: 10.1159/000020250.
Results Reference
background
PubMed Identifier
11832726
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.
Results Reference
background
PubMed Identifier
17705753
Citation
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. doi: 10.1089/end.2007.9949.
Results Reference
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PubMed Identifier
1635117
Citation
Hubner 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. doi: 10.1016/s0022-5347(17)36572-2.
Results Reference
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PubMed Identifier
7693295
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. doi: 10.1111/j.1464-410x.1993.tb00728.x.
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PubMed Identifier
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Citation
Laaksovirta S, Valimaa T, Isotalo T, Tormala 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. doi: 10.1097/01.ju.0000076389.88489.af.
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PubMed Identifier
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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. doi: 10.1186/1471-2490-2-12. Epub 2002 Nov 11.
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PubMed Identifier
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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. doi: 10.1046/j.1464-410x.2002.02888.x.
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Tolerance and Effectiveness of Ureteral Stents MEMOKATH ® 051 in Chronic Strictures of the Ureter
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