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

NCT ID: NCT04031911

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2022-11-01

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.

Conditions

Calculi, Urinary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

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.).

Group Type: OTHER

Standard support in urology

Intervention Type: DEVICE

Dispensing of AFU plugs Dietary advice

Study group

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

Group Type: EXPERIMENTAL

Hydroposturotherapy

Intervention Type: DEVICE

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

Interventions

Hydroposturotherapy

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

Intervention Type: DEVICE

Standard support in urology

Dispensing of AFU plugs Dietary advice

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Association Francaise pour la Recherche Thermale

OTHER

Sponsor Role: collaborator

Conseil National des Etablissements Thermaux

UNKNOWN

Sponsor Role: collaborator

GUILLEMIN Francis, MD

OTHER

Sponsor Role: lead

Responsible Party

GUILLEMIN Francis, MD

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jacques HUBERT, PH

Role: PRINCIPAL_INVESTIGATOR

Central Hospital, Nancy, France

Locations

CHRU

Nancy, , France

Countries

France

Other Identifiers

2018-A00570-55 LITHUTHERM

Identifier Type: -

Identifier Source: org_study_id