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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)

G

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status

Enrolling

Conditions

Stone, Kidney

Treatments

Behavioral: SELF POSTUROTHERAPIE

Study type

Interventional

Funder types

Other

Identifiers

NCT06793540
2024-A02267-40 (Other Identifier)
2023-06-024-ALMERAS(ALUR)

Details and patient eligibility

About

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.

Enrollment

216 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

216 participants in 2 patient groups

self-posturotherapy
Experimental group
Description:
standard care (according to recommendations) + self-posturotherapy program
Treatment:
Behavioral: SELF POSTUROTHERAPIE
Standard care
No Intervention group
Description:
standard care alone (according to recommendations)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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