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Ureteral ObstructionPhase 2TOTEMENCT00790686

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

A Phase 2 study testing Insertion of Memokath 051 in people with Ureteral Obstruction, run by University Hospital, Bordeaux at 4 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ureteral Obstruction
What is being tested?
Insertion of Memokath 051
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
4 sitesFrance
Study dates
Nov 2008to May 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • Department of Urology, University Hospital, Bordeaux

    Bordeaux, 22076

  • Department of Urology, University Hospital, Limoges

    Limoges, 87042

  • Department of Urology, Hospices Civils de Lyon

    Lyon, 69437

  • Department of Urology, University Hospital, Toulouse

    Toulouse, 31059

Other trials in France

About this study

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

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.

Read the 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.

Being tested
Insertion of Memokath 051
Keywords
Ureteral obstruction, Urologic surgical procedure, Stents, Endoscopy, Urology
Medical subject headings
Ureteral Obstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insertion of Memokath 051Procedure or surgery

    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 groups in NCT00790686
Study groupRoleWhat they receive
1ExperimentalMemokath 051
Receives: Procedure: Insertion of Memokath 051

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average durability of the stent MEMOKATH ® 051

    Measured: 3 years

Secondary outcomes (5)

  1. Proportion of ureteral stent MEMOKATH ® 051 positioning failure

    Measured: 3 years

  2. Average quality of life of the patients measured by auto-questionary

    Measured: 3 years

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

    Measured: 3 years

  4. Expense of hospitalizations for replacement of the ureteral stent

    Measured: 3 years

  5. Proportion of replacement of the ureteral stent

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionMay 2013
  4. Study completionMay 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00790686
Sponsor's protocol ID
CHUBX2008/24
Acronym
TOTEME
Status last verified
Aug 2014
First submitted
12 Nov 2008
Last updated
14 May 2026
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 11586216

  • 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.

    PubMed 16019773

  • 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.

    PubMed 16475655

  • 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.

    PubMed 10859440

  • 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.

    PubMed 11832726

  • 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.

    PubMed 17705753

  • 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.

    PubMed 1635117

  • 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.

    PubMed 7693295

  • 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.

    PubMed 12853801

  • 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.

    PubMed 12427256

  • 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.

    PubMed 12133055

  • 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.

    PubMed 11564017

  • Azizi A, Pasticier G, Benard A, Lapouge O, Ferriere JM, Ballanger P, Robert G. [Tolerance and effectiveness of Memokath(R) 051 ureteral stents : a prospective 3 year follow-up study]. Prog Urol. 2012 May;22(5):266-72. doi: 10.1016/j.purol.2012.01.002. Epub 2012 Feb 2. French.

    PubMed 22515922

  • Forgues A, Junes F, Gateau T, Geissman A, Merignargues F, Ballanger P, Robert G. [Right obstructive pyelonephritis due to supra-piriform herniation of the pelvic ureter: a clinical case]. Prog Urol. 2011 Nov;21(12):887-90. doi: 10.1016/j.purol.2011.02.003. Epub 2011 Apr 1. French.

    PubMed 22035916

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Insertion of Memokath 051 in people with Ureteral Obstruction, run by University Hospital, Bordeaux at 4 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average durability of the stent MEMOKATH ® 051 (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00790686, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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