Study of the Benefits of a Short Spa Treatment on the Elimination of Residual Lithic Fragments After Treatment (LITHUTHERM)
Primary Purpose
Calculi, Urinary
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hydroposturotherapy
Standard support in urology
Sponsored by
About this trial
This is an interventional treatment trial for Calculi, Urinary focused on measuring Urinary lithiasis, Urological treatments, Spa treatment, Posturotherapy, Lumbar percussions, Hyperdiuresis
Eligibility Criteria
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
Sites / Locations
- CHRU
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Control group
Study group
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Number of participants with complications related to residual stones or their evacuation
Complications may include renal colic, low back pain, urinary tract infections
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.
Number of intercurrent events
renal colic, infection, hematuria), work stoppages, medical prescriptions, hospitalizations, urological procedures.
Medico-economic study of the benefit of the thermal cure
Study of the benefits of hydroposturotherapy in terms of avoided management costs
Full Information
NCT ID
NCT04031911
First Posted
July 17, 2019
Last Updated
February 6, 2023
Sponsor
GUILLEMIN Francis, MD
Collaborators
Association Francaise pour la Recherche Thermale, Conseil National des Etablissements Thermaux
1. Study Identification
Unique Protocol Identification Number
NCT04031911
Brief Title
Study of the Benefits of a Short Spa Treatment on the Elimination of Residual Lithic Fragments After Treatment
Acronym
LITHUTHERM
Official Title
Study of the Benefits of a Short Spa Treatment on the Elimination of Residual Lithic Fragments After Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
lack of enrollment due to covid 19
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
November 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
GUILLEMIN Francis, MD
Collaborators
Association Francaise pour la Recherche Thermale, Conseil National des Etablissements Thermaux
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calculi, Urinary
Keywords
Urinary lithiasis, Urological treatments, Spa treatment, Posturotherapy, Lumbar percussions, Hyperdiuresis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Other
Arm Description
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.).
Arm Title
Study group
Arm Type
Experimental
Arm Description
Study group benefiting from a short spa treatment (5 days) with hydroposturotherapy ("HPT" arm) in Vittel or Capvern: posturotherapy, lumbar percussion and controlled hyperdiuresis.
Intervention Type
Device
Intervention Name(s)
Hydroposturotherapy
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Standard support in urology
Intervention Description
Dispensing of AFU plugs Dietary advice
Primary Outcome Measure Information:
Title
Rate of SF patients (without fragment / stone free) in each arm, on the scanner and on the ASP.
Description
Estimate of the rate of patients for whom all fragments have been eliminated
Time Frame
3 months after the patient's urological management
Secondary Outcome Measure Information:
Title
Size of residual fragments in the cavities of the treated kidney at 3 months.
Description
The size of the residual fragments will be measured in millimetres
Time Frame
3 months after the patient's urological management
Title
Number of participants with complications related to residual stones or their evacuation
Description
Complications may include renal colic, low back pain, urinary tract infections
Time Frame
At inclusion, 1 month after inclusion, 3 months after inclusion
Title
Quality of life questionnaire SF 36 : The Short Form (36) Health Survey
Description
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.
Time Frame
At inclusion, 1 month after inclusion, 3 months after inclusion
Title
Number of intercurrent events
Description
renal colic, infection, hematuria), work stoppages, medical prescriptions, hospitalizations, urological procedures.
Time Frame
At inclusion, 1 month after inclusion, 3 months after inclusion
Title
Medico-economic study of the benefit of the thermal cure
Description
Study of the benefits of hydroposturotherapy in terms of avoided management costs
Time Frame
3 months after inclusion of patients in the cure group
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques HUBERT, PH
Organizational Affiliation
Central Hospital, Nancy, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU
City
Nancy
ZIP/Postal Code
54000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of the Benefits of a Short Spa Treatment on the Elimination of Residual Lithic Fragments After Treatment
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