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

NCT04031911 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2023-02-08

No results posted yet for this study

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.

Conditions

  • Calculi, Urinary

Interventions

DEVICE

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

DEVICE

Standard support in urology

Dispensing of AFU plugs Dietary advice

Sponsors & Collaborators

  • Association Francaise pour la Recherche Thermale

    collaborator OTHER

  • Conseil National des Etablissements Thermaux

    collaborator UNKNOWN

  • GUILLEMIN Francis, MD

    lead OTHER

Principal Investigators

  • Jacques HUBERT, PH · Central Hospital, Nancy, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2021-10-01
Completion
2022-11-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04031911 on ClinicalTrials.gov