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

NCT00790686 | Completed Phase 2 DMC

• 1 other identifier: CHUBX2008/24
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 4

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.

Conditions

Ureteral Obstruction

Keywords

Ureteral obstruction; Urologic surgical procedure; Stents; Endoscopy; Urology

Outcome Measures

Primary Outcomes (1)

• Average durability of the stent MEMOKATH ® 051

  3 years

Secondary Outcomes (5)

• Proportion of ureteral stent MEMOKATH ® 051 positioning failure

  3 years

• Average quality of life of the patients measured by auto-questionary

  3 years

• Proportion of patients to which the ureteral stent was definitely taken away

  3 years

• Expense of hospitalizations for replacement of the ureteral stent

  3 years

• Proportion of replacement of the ureteral stent

  3 years

Study Arms (1)

1

EXPERIMENTAL

Memokath 051

Procedure: Insertion of Memokath 051

Interventions

Insertion of Memokath 051 PROCEDURE

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (4)

Department of Urology, University Hospital, Bordeaux

Bordeaux, 22076, France

Location

Department of Urology, University Hospital, Limoges

Limoges, 87042, France

Location

Department of Urology, Hospices Civils de Lyon

Lyon, 69437, France

Location

Department of Urology, University Hospital, Toulouse

Toulouse, 31059, France

Location

Related Publications (12)

• 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.

  PMID: 11586216 BACKGROUND

• 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.

  PMID: 16019773 BACKGROUND

• 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.

  PMID: 16475655 BACKGROUND

• 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.

  PMID: 10859440 BACKGROUND

• 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.

  PMID: 11832726 BACKGROUND

• 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.

  PMID: 17705753 BACKGROUND

• 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.

  PMID: 1635117 BACKGROUND

• 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.

  PMID: 7693295 BACKGROUND

• 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.

  PMID: 12853801 BACKGROUND

• 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.

  PMID: 12427256 BACKGROUND

• 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.

  PMID: 12133055 BACKGROUND

• 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. doi: 10.1046/j.1464-410x.2001.02322.x.

  PMID: 11564017 BACKGROUND

MeSH Terms

Conditions

Ureteral Obstruction

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Gregoire Robert, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Antoine BENARD, MD

  University Hospital, Bordeaux

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2008
• First Posted: November 13, 2008
• Study Start: November 1, 2008
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: August 21, 2014

Record last verified: 2014-08

Locations

FR (4)