Effectiveness of Self-posturotherapy on the Elimination of Residual Fragments After Treatment of Lower Calyx Urinary Stones by Extracorporeal Lithotripsy or Retrograde Flexible Ureteroscopy.

NCT06793540 | Recruiting

• 2 other identifiers: 2023-06-024-ALMERAS(ALUR)2024-A02267-40
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Stone, Kidney

Outcome Measures

Primary Outcomes (1)

• stone free rate

  3 month

Study Arms (2)

self-posturotherapy

EXPERIMENTAL

standard care (according to recommendations) + self-posturotherapy program

Behavioral: SELF POSTUROTHERAPIE

Standard care

NO INTERVENTION

standard care alone (according to recommendations)

Interventions

SELF POSTUROTHERAPIE BEHAVIORAL

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.

self-posturotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (2)

Hôpital Edouard Herriot -

Lyon, 69003, France

RECRUITING

Clinique La Croix du Sud

Quint-Fonsegrives, 31130, France

RECRUITING

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Model Description

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 27, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)