Clinical trial NCT04031911: Study of the Benefits of a Short Spa Treatment on the Elimination of Residual Lithic Fragments After Treatment
Official title: Study of the Benefits of a Short Spa Treatment on the Elimination of Residual Lithic Fragments After Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Calculi, Urinary
Keywords: Urinary lithiasis
Urological treatments
Spa treatment
Posturotherapy
Lumbar percussions
Hyperdiuresis
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: Association Francaise pour la Recherche Thermale
name: Conseil National des Etablissements Thermaux
First posted: 2019-07-24
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This clinical study will be organized in 2 arms:

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

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of SF patients (without fragment / stone free) in each arm, on the scanner and on the ASP.
timeFrame: 3 months after the patient's urological management
Secondary outcomes:
measure: Size of residual fragments in the cavities of the treated kidney at 3 months.
timeFrame: 3 months after the patient's urological management
measure: Number of participants with complications related to residual stones or their evacuation
timeFrame: At inclusion, 1 month after inclusion, 3 months after inclusion
measure: Quality of life questionnaire SF 36 : The Short Form (36) Health Survey
timeFrame: At inclusion, 1 month after inclusion, 3 months after inclusion
measure: Number of intercurrent events
timeFrame: At inclusion, 1 month after inclusion, 3 months after inclusion
measure: Medico-economic study of the benefit of the thermal cure
timeFrame: 3 months after inclusion of patients in the cure group
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU
Study officials:
affiliation: Central Hospital, Nancy, France
name: Jacques HUBERT, PH
role: PRINCIPAL_INVESTIGATOR
References: