Clinical trial NCT05872230: Massage Percussion for Passage of Urolithiasis Fragments After Ureteroscopy.
Official title: Massage Percussion Therapy for Passage of Urolithiasis Fragments After Ureteroscopy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Nephrolithiasis
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Flexible ureteroscopy is characterized as first-line therapy for renal stones \< 2 cm in size. Stones are commonly treated with dusting or fragmentation techniques which requires passage of stone fragments after surgery. Quoted stone free rate after flexible ureteroscopy is approximately 40-60% with a dusting technique. Residual fragments are often under 1mm in size and can layer in the lower pole of the kidney, complicating spontaneous stone passage. Improving the stone free rate after surgery decreases the need for secondary surgeries and decreases risk of future stone events.

Numerous techniques have been proposed to increase stone passage including positional changes and percussion therapy. To date, there is overall limited data a lack of techniques that can be readily available in the outpatient setting, easily added to scheduled appointments, reproducible results and well tolerated by patients.

Detailed description: Researchers in China have developed a proprietary oscillation machine to be used in an outpatient setting. The External Physical Vibration Lithecbole (EPVL) is used to provide vibration after stone fragmentation to facilitate movement of fragments into a more favorable orientation for stone passage. After extracorporeal shockwave lithotripsy and ureteroscopy, use of EPVL after surgery has been shown to increase stone free rate.

Chest percussion for cystic fibrosis patients has been adapted for use after ureteroscopy. After undergoing extracorporeal shockwave lithotripsy, patients are placed in a percussion physiotherapy vest, given diuretics and positioned in Trendelenburg. Imaging obtained before and after percussion demonstrates successful stone movement and increases stone free rates in several different protocols compared to patients who do not receive percussive therapy.

Percussion therapy is clearly effective to improve stone free rates after ureteroscopy and is effective regardless of technique, protocol, or percussive device. However, proposed techniques with EPVL and chest physiotherapy vests can be expensive, cumbersome and require specialty equipment. In addition, proposed equipment in prior studies is not readily available in outpatient clinics.

Eligibility criteria: Inclusion Criteria:

* Any patient after treatment of renal stones with ureteroscopy during which residual stone fragments (less than 2mm by surgeon estimation) is left in the kidney.
* Must be 18 years or older
* Must be able to give consent
* Preoperative abdominal CT

Exclusion Criteria:

* On pharmacologic anticoagulation. Aspirin up to 81mg will be allowed.
* Cannot tolerate flank, prone or Trendelenburg position.
* Cannot tolerate percussion.
* History of acute rib fractures or osteopenia/osteoporosis.
* Any patient who is on a fluid intake restriction.
* Pregnancy
* Untreated UTI
* History of struvite stones
* Requiring a planned secondary stone procedure within 90 days
* If stent must stay in longer than 10 days
* Ureteral stones (without renal stones)

Primary outcomes:
measure: Patients who are able to tolerate and complete the percussion therapy.
timeFrame: Postop day 0-10.
measure: Stone Free Rate.
timeFrame: 6 weeks after surgery.
Secondary outcomes:
measure: weight of passed stone fragments
timeFrame: 6 weeks.
measure: Unplanned return visits.
timeFrame: 6 weeks.
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: University of Montreal
Study officials:
affiliation: VUMC
name: Ryan Hsi
role: PRINCIPAL_INVESTIGATOR
References: