Study of the Benefits of a Short Spa Treatment on the Elimination of Residual Lithic Fragments After Treatment (LITHUTHERM)

  • STATUS
    Recruiting
  • days left to enroll
    28
  • participants needed
    190
  • sponsor
    GUILLEMIN Francis, MD
Updated on 2 March 2022

Summary

Current urological therapeutic modalities are represented by extracorporeal lithotripsy (ECL), rigid (URS) or flexible (URSsple) uretero-renoscopy and percutaneous nephrolithotomy (PCNL).

They make it possible to extract the vast majority of stones by minimally invasive techniques but leave behind small residual lithic fragments (FR) that can always cause pain, infection, or promote the development of a larger stone.

A non-invasive technique that can help eliminate them would be of great benefit to many patients by avoiding painful recurrences and limiting reprocessing; combined with appropriate medical management, it would limit the rate of remote recurrences and long-term complications.

The treatment called "hydro-posturotherapy" has been developed in some spas that are approved for kidney diseases such as Vittel or Capvern. It includes several modalities: posturotherapy, lumbar percussion and hyperdiuresis.

The main objective is to compare at 3 months, on the unprepared abdomen (ASP) and the low-dose scanner without injection, the elimination of kidney stone fragments under the effect of a short spa treatment with posturotherapy, lumbar percussion and controlled hyperdiuresis compared to the recommended standard treatment. The result will be assessed in 3 categories: complete elimination (SF: "without fragments" or "stone-free"), elimination of more than 50% of the fragments; elimination of less than 50% of the fragments.

Description

Randomized multicenter controlled clinical trial comparing hydroposturotherapy in short thermal cure with standard hyperdiuresis in patients with residual stones, especially lower caliciels after urological treatment.

5 inclusion centres

  • Central Hospital, Nancy
  • Nancy Urology Center
  • Clinique de la Croix du Sud in Toulouse
  • Edouard Herriot Hospital in Lyon

The radiological images will be reviewed by the radiology department of the Central Hospital, Nancy.

Details
Condition Calculi, Urinary
Treatment Hydroposturotherapy, Standard support in urology
Clinical Study IdentifierNCT04031911
SponsorGUILLEMIN Francis, MD
Last Modified on2 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Major patients with urinary stones who have received minimally invasive urological treatment: extracorporeal lithotripsy (ECL), flexible uretero-renoscopy (URSsple) and percutaneous nephrolithotomy (NLPC)
Patients with kidney stones less than 4 mm in size who are not receiving minimally invasive therapy
Evaluation of the number, size / volume and location of calculations by ASP & TDM low-dose, without post-operative injection
Information and signature of informed consent

Exclusion Criteria

Patients refusing a spa treatment
Contraindications to PTH: morbid obesity, unbalanced hypertension, pregnancy, respiratory failure, dizziness, vascular and/or ocular disorders, poly-mediated unbalanced cardiovascular pathology, orthostatic hypotension, general condition of the patient incompatible with the treatment
Patients with Cacchi Ricci disease
Person under the protection of justice, guardianship or curatorship
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