Calculi, UrinaryLITHUTHERMNCT04031911
Study of the Benefits of a Short Spa Treatment on the Elimination of Residual Lithic Fragments After Treatment
A study testing Hydroposturotherapy and Standard support in urology in people with Calculi, Urinary, run by GUILLEMIN Francis, MD at 1 site in France.
Trial summary
Current urological therapeutic modalities are represented by extracorporeal lithotripsy (ECL), rigid (URS) or flexible (URSsple) uretero-renoscopy and percutaneous nephrolithotomy (PCNL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Calculi, Urinary
- What is being tested?
- Hydroposturotherapy and Standard support in urology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2019to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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
- Being tested
- Hydroposturotherapy, Standard support in urology
- Keywords
- Urinary lithiasis, Urological treatments, Spa treatment, Posturotherapy, Lumbar percussions, Hyperdiuresis
- Medical subject headings
- Urinary Calculi, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydroposturotherapyDevice
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 urologyDevice
Dispensing of AFU plugs Dietary advice
| Study group | Role | What they receive |
|---|---|---|
| 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.). Receives: 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. Receives: Device: Hydroposturotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
The size of the residual fragments will be measured in millimetres
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 3 months after inclusion of patients in the cure group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start1 Aug 2019
- Primary completion1 Oct 2021
- Study completion1 Nov 2022
Why it stopped: lack of enrollment due to covid 19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calculi, UrinaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GUILLEMIN Francis, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Association Francaise pour la Recherche Thermale, Conseil National des Etablissements Thermaux
- Responsible party
- Sponsor-investigator, GUILLEMIN Francis, MD, Central Hospital, Nancy, France
- Investigators
- Jacques HUBERT, PH, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031911
- Sponsor's protocol ID
- 2018-A00570-55 LITHUTHERM
- Acronym
- LITHUTHERM
- Status last verified
- Feb 2023
- First submitted
- 17 Jul 2019
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Benefits of a Short Spa Treatment on the Elimination of Residual Lithic Fragments After Treatment
- ClinicalTrials.gov ID
- NCT04031911
- Acronym / sponsor ID
- LITHUTHERM / 2018-A00570-55 LITHUTHERM
- Conditions
- Calculi, Urinary
- Keywords
- Urinary lithiasis, Urological treatments, Spa treatment, Posturotherapy, Lumbar percussions, Hyperdiuresis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of enrollment due to covid 19
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GUILLEMIN Francis, MDUniversity, hospital or other
- Collaborators
- Association Francaise pour la Recherche Thermale, Conseil National des Etablissements Thermaux
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 24 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Device: Standard support in urologyControl 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 | Experimental | Device: HydroposturotherapyStudy group benefiting from a short spa treatment (5 days) with hydroposturotherapy ("HPT" arm) in Vittel or Capvern: posturotherapy, lumbar percussion and controlled hyperdiuresis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydroposturotherapyHydroposturotherapy 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 | Study group |
| Standard support in urologyDispensing of AFU plugs Dietary advice | Device | Control group |
Primary outcome
Rate of SF patients (without fragment / stone free) in each arm, on the scanner and on the ASP.
Time frame: 3 months after the patient's urological management
Estimate of the rate of patients for whom all fragments have been eliminated
5 secondary outcomes
Size of residual fragments in the cavities of the treated kidney at 3 months.
Time frame: 3 months after the patient's urological management
Number of participants with complications related to residual stones or their evacuation
Time frame: At inclusion, 1 month after inclusion, 3 months after inclusion
Quality of life questionnaire SF 36 : The Short Form (36) Health Survey
Time frame: At inclusion, 1 month after inclusion, 3 months after inclusion
Number of intercurrent events
Time frame: At inclusion, 1 month after inclusion, 3 months after inclusion
Medico-economic study of the benefit of the thermal cure
Time frame: 3 months after inclusion of patients in the cure group
Results and safety
The study was stopped early (reason given: lack of enrollment due to covid 19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques HUBERT, PH principal investigator
Central Hospital, Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydroposturotherapy and Standard support in urology in people with Calculi, Urinary, run by GUILLEMIN Francis, MD at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of enrollment due to covid 19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of SF patients (without fragment / stone free) in each arm, on the scanner and on the ASP. (time frame: 3 months after the patient's urological management). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.