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

GUILLEMIN Francis, MD

Status: Terminated

Conditions: Calculi, Urinary

Treatments: Device: Hydroposturotherapy; Device: Standard support in urology

Study type: Interventional

Funder types: Other

Identifiers

NCT04031911

2018-A00570-55 LITHUTHERM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Control group

Other group

Description:

Control group benefiting from standard support (AFU (Association Française d'Urologie) information sheet), but applied in a more supervised way (communication document, process studies, etc.).

Treatment:

Device: Standard support in urology

Study group

Experimental group

Description:

Study group benefiting from a short spa treatment (5 days) with hydroposturotherapy ("HPT" arm) in Vittel or Capvern: posturotherapy, lumbar percussion and controlled hyperdiuresis.

Treatment:

Device: Hydroposturotherapy