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

NCT04031911 | Terminated

• 1 other identifier: 2018-A00570-55 LITHUTHERM
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Calculi, Urinary

Keywords

Urinary lithiasis; Urological treatments; Spa treatment; Posturotherapy; Lumbar percussions; Hyperdiuresis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

Control group

OTHER

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

Study group

EXPERIMENTAL

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

Interventions

Hydroposturotherapy 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

Study group

Standard support in urology DEVICE

Dispensing of AFU plugs Dietary advice

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GUILLEMIN Francis, MD: lead
• Association Francaise pour la Recherche Thermale: collaborator
• Conseil National des Etablissements Thermaux: collaborator

Study Sites (1)

CHRU

Nancy, 54000, France

Location

MeSH Terms

Conditions

Urinary Calculi; Urolithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Jacques HUBERT, PH

  Central Hospital, Nancy, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 24, 2019
• Study Start: August 1, 2019
• Primary Completion: October 1, 2021
• Study Completion: November 1, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)