- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06793540
Effectiveness of Self-posturotherapy on the Elimination of Residual Fragments After Treatment of Lower Calyx Urinary Stones by Extracorporeal Lithotripsy or Retrograde Flexible Ureteroscopy. (ALUR)
July 2, 2025 updated by: GCS Ramsay Santé pour l'Enseignement et la Recherche
The main objective of this study is to evaluate the effectiveness of an auto posturotherapy technique on the RFS at three months of patients treated for lower calyceal urinary stones by extracorporeal lithotripsy (ECL) or retrograde flexible ureteroscopy.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
216
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lyon, France, 69003
- Recruiting
- Hôpital Edouard Herriot -
-
Contact:
- Nadia ABID -, Dr
- Phone Number: 04 72 11 80 88
- Email: nadia.abid@chu-lyon.fr
-
Quint-Fonsegrives, France, 31130
- Recruiting
- Clinique La Croix Du Sud
-
Contact:
- Christophe ALMERAS, Dr
- Phone Number: +33 05 36 28 00 00
- Email: c.almeras@gmail.com
-
Principal Investigator:
- Christophe ALMERAS, Dr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
pré Inclusion Criteria:
- Patient having read and signed the consent form for participation in the study • Patient candidate for an intervention on a lower calyx stone <15mm by LEC or URSS
Patients meeting all of the following criteria may be definitively included in the study:
- Patient treated by LEC, or patient treated by URSS and for whom the presence of lower calyceal fragments has been observed by endoscopy
- Absence of JJ stent (patients for whom a JJ stent was implanted after URSS or before LEC may be included as soon as it is removed)
Exclusion Criteria:
Patients presenting one of the following criteria will not be included in the study:
- Renal or ureteral malformation: ureteral stenosis, pyelo-ureteral junction syndrome, horseshoe kidney, para calyceal diverticulum, pelvic kidney.
- LEC session interrupted due to treatment intolerance
- Physical disability making posturotherapy impossible (particularly spinal, etc.), morbid obesity, major gastroesophageal reflux, heart or respiratory failure.
- Balance disorder which would not allow self-posturotherapy to be carried out alone.
- Patient under legal protection, under guardianship or under curatorship
- Posturotherapy carried out while wearing a JJ probe
- Posturotherapy carried out by a third party (physiotherapist or other)
- Pregnant or breastfeeding patient
- Patient not affiliated to the French social security system
- Impossibility of providing the subject with informed information and/or giving written informed consent: dementia, psychosis, disorders of consciousness, non-French speaking patient
- Treatment that may modify the clearance of fragments (beta blocker, diuretic, etc.)
- Patient included in another therapeutic study protocol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: self-posturotherapy
standard care (according to recommendations) + self-posturotherapy program
|
a simplified posturotherapy protocol that can be carried out by the patient himself.
This protocol is based on the same principles as posturotherapy carried out by a physiotherapist by combining inclined positioning, percussion and diuresis.
|
|
No Intervention: Standard care
standard care alone (according to recommendations)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
stone free rate
Time Frame: 3 month
|
3 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 30, 2025
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2027
Study Registration Dates
First Submitted
January 20, 2025
First Submitted That Met QC Criteria
January 20, 2025
First Posted (Actual)
January 27, 2025
Study Record Updates
Last Update Posted (Estimated)
July 8, 2025
Last Update Submitted That Met QC Criteria
July 2, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-06-024-ALMERAS(ALUR)
- 2024-A02267-40 (Other Identifier: Numéro ID RCB ( ANSM))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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