NCT04031911

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: GUILLEMIN Francis, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-08-01
• Primary completion: 2021-10-01
• Completion: 2022-11-01
• First posted: 2019-07-24
• Last updated: 2023-02-08

Locations

1 site across 1 country: France