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

Calculi, Urinary Clinical Trial

— LITHUTHERM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04031911
• Other study ID #: 2018-A00570-55 LITHUTHERM
• Status: Terminated
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: November 1, 2022

Study information

• Verified date: February 2023
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: November 1, 2022
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Calculi
• Calculi, Urinary
• Urinary Calculi

Intervention

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
• Standard support in urology
Dispensing of AFU plugs Dietary advice

Locations

Country	Name	City	State
France	CHRU	Nancy

Sponsors (3)

Lead Sponsor	Collaborator
GUILLEMIN Francis, MD	Association Francaise pour la Recherche Thermale, Conseil National des Etablissements Thermaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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