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NCT04031911: LITHUTHERM
Study of the Benefits of a Short Spa Treatment on the Elimination of Residual Lithic Fragments After Treatment
NA trial testing Hydroposturotherapy in Calculi, Urinary in 1 participant. Terminated before completion.
1 October 2021
Quick facts
| Lead sponsor | GUILLEMIN Francis, MD |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 1 August 2019 |
| Primary completion | 1 October 2021 |
| Estimated completion | 1 November 2022 |
| Sites | 1 location across France |
Drugs / interventions tested
- Hydroposturotherapy
- Standard support in urology
Conditions studied
- Calculi, Urinary — all drugs for Calculi, Urinary →
Sponsor
GUILLEMIN Francis, MD
Who can join
18 and older, any sex, with Calculi, Urinary. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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- PubMed search for NCT04031911
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Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04031911 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by GUILLEMIN Francis, MD
- Last refreshed: 8 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04031911.
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