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

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

Patrocinadores

Patrocinador principal: GUILLEMIN Francis, MD

Colaborador: Association Francaise pour la Recherche Thermale
Conseil National des Etablissements Thermaux

Fuente Central Hospital, Nancy, France
Resumen breve

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.

Descripción detallada

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.

Estado general Recruiting
Fecha de inicio August 1, 2019
Fecha de Terminación November 1, 2022
Fecha de finalización primaria October 1, 2021
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Rate of SF patients (without fragment / stone free) in each arm, on the scanner and on the ASP. 3 months after the patient's urological management
Resultado secundario
Medida Periodo de tiempo
Size of residual fragments in the cavities of the treated kidney at 3 months. 3 months after the patient's urological management
Number of participants with complications related to residual stones or their evacuation At inclusion, 1 month after inclusion, 3 months after inclusion
Quality of life questionnaire SF 36 : The Short Form (36) Health Survey At inclusion, 1 month after inclusion, 3 months after inclusion
Number of intercurrent events At inclusion, 1 month after inclusion, 3 months after inclusion
Medico-economic study of the benefit of the thermal cure 3 months after inclusion of patients in the cure group
Inscripción 190
Condición
Intervención

Tipo de intervención: Device

Nombre de intervención: Hydroposturotherapy

Descripción: Hydroposturotherapy combines: posturotherapy (patient placed upside down with water jets sent to the kidneys) lumbar percussion hyperdiuresis: prescribed quantities of water to be absorbed by the patient

Etiqueta de grupo de brazo: Study group

Tipo de intervención: Device

Nombre de intervención: Standard support in urology

Descripción: Dispensing of AFU plugs Dietary advice

Etiqueta de grupo de brazo: Control group

Elegibilidad

Criterios:

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

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Jacques HUBERT, PH Principal Investigator Central Hospital, Nancy, France
Contacto general

Apellido: Francis GUILLEMIN, PH

Teléfono: 0383852852

Email: [email protected]

Ubicación
Instalaciones: Estado: CHRU
Ubicacion Paises

France

Fecha de verificación

July 2019

Fiesta responsable

Tipo: Sponsor-Investigator

Afiliación del investigador: Central Hospital, Nancy, France

Nombre completo del investigador: GUILLEMIN Francis, MD

Título del investigador: Professor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Control group

Tipo: Other

Descripción: 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.).

Etiqueta: Study group

Tipo: Experimental

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

Acrónimo LITHUTHERM
Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Descripción del modelo de intervención: 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.

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov