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

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.

Study Overview

• Status: Terminated
• Conditions: Calculi, Urinary
• Intervention / Treatment: Device: Standard support in urology; Device: Hydroposturotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francis GUILLEMIN, PH; Phone Number: 0383852852; Email: francis.guillemin@chru-nancy.fr
• Study Contact Backup: Name: Amandine ZIEGLER; Phone Number: 0383852852; Email: a.ziegler@chru-nancy.fr

Study Locations

• France
  • Nancy, France, 54000
    • CHRU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.).	Device: Standard support in urology; Dispensing of AFU plugs Dietary advice
EXPERIMENTAL: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of SF patients (without fragment / stone free) in each arm, on the scanner and on the ASP.	Estimate of the rate of patients for whom all fragments have been eliminated	3 months after the patient's urological management

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Size of residual fragments in the cavities of the treated kidney at 3 months.	The size of the residual fragments will be measured in millimetres	3 months after the patient's urological management
Number of participants with complications related to residual stones or their evacuation	Complications may include renal colic, low back pain, urinary tract infections	At inclusion, 1 month after inclusion, 3 months after inclusion
Quality of life questionnaire SF 36 : The Short Form (36) Health Survey	The SF 36 questionnaire is a questionnaire measuring quality of life with 36 items grouped into 8 scales: physical activity, limitation/physical state, physical pain, perceived health, vitality, life/relationships, psychological health, limitation/psychological state The SF-36 is not suitable for producing an overall summary score. Indeed, the information in the individual responses is lost in the total score of the scale (since the total score can be obtained in different ways from the individual responses of the items). The recommended rating system for SF-36 is a Likert weighted system for each item. The items in the subscales are totalled to obtain a summary score for each subscale or dimension. Each of the 8 summary scores is linearly transformed on a scale from 0 (negative for health) to 100 (positive for health) to obtain a score for each subscale.	At inclusion, 1 month after inclusion, 3 months after inclusion
Number of intercurrent events	renal colic, infection, hematuria), work stoppages, medical prescriptions, hospitalizations, urological procedures.	At inclusion, 1 month after inclusion, 3 months after inclusion
Medico-economic study of the benefit of the thermal cure	Study of the benefits of hydroposturotherapy in terms of avoided management costs	3 months after inclusion of patients in the cure group

Collaborators and Investigators

• Sponsor: GUILLEMIN Francis, MD
• Collaborators: Association Francaise pour la Recherche Thermale; Conseil National des Etablissements Thermaux
• Investigators: Principal Investigator: Jacques HUBERT, PH, Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2019
• Primary Completion (ACTUAL): October 1, 2021
• Study Completion (ACTUAL): November 1, 2022

Study Registration Dates

• First Submitted: July 17, 2019
• First Submitted That Met QC Criteria: July 23, 2019
• First Posted (ACTUAL): July 24, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Spa treatment; Urinary lithiasis; Urological treatments; Posturotherapy; Lumbar percussions; Hyperdiuresis
• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi
• Other Study ID Numbers: 2018-A00570-55 LITHUTHERM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No