Self-posturotherapy to clear leftover fragments after lower-pole kidney stone treatment

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

This trial will test whether a simple home posturotherapy technique helps people treated with extracorporeal lithotripsy or flexible ureteroscopy for lower-pole kidney stones get rid of remaining fragments over three months.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 216 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche (Academic / other)
• Locations: 2 sites (Lyon and 1 other locations)
• Trial ID: NCT06793540 on ClinicalTrials.gov

What this trial studies

Adults treated for lower calyx kidney stones (<15 mm) by extracorporeal lithotripsy (LEC) or retrograde flexible ureteroscopy (URSS) who have residual lower-pole fragments will be taught and asked to perform a self-posturotherapy positioning program at home. Patients with temporary JJ stents must have them removed before inclusion, and those with renal/ureteral malformations or physical limitations are excluded. The main outcome is the presence or absence of residual fragments at three months documented by imaging or endoscopy. The approach aims to mobilize and promote passage of fragments noninvasively to reduce the need for additional procedures.

Who should consider this trial

Good fit: Adults who consent and who were treated for a lower calyx stone under 15 mm by LEC or URSS with documented lower-pole residual fragments, who have no JJ stent in place and who can perform the positioning exercises, are ideal candidates.

Not a fit: Patients with renal or ureteral malformations, those with a JJ stent in place, patients whose LEC was interrupted for intolerance, or individuals with physical limitations, morbid obesity, or severe reflux that prevent safe posturotherapy are unlikely to benefit.

Why it matters

Potential benefit: If successful, this could increase complete stone clearance after lower-pole procedures without additional invasive treatments.

How similar studies have performed: Small prior studies of positional maneuvers for lower-pole stone clearance have suggested benefit but evidence is limited, so this structured self-posturotherapy approach remains relatively untested at scale.

Eligibility 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

Where this trial is running

Lyon and 1 other locations

• Hôpital Edouard Herriot - — Lyon, France (Recruiting)
• Clinique La Croix du Sud — Quint-Fonsegrives, France (Recruiting)

Conditions Stone, Kidney