Massage Percussion for Passage of Urolithiasis Fragments After Ureteroscopy.

NCT ID: NCT05872230

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2025-05-15

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.

Conditions

Nephrolithiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Patient receives standard postoperative care with no percussion therapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

PACU percussion

Patient receives percussion therapy in the PACU immediately after surgery.

Group Type: EXPERIMENTAL

Massage Percussion Therapy device

Intervention Type: DEVICE

Using massage percussion postoperatively.

Postoperative appointment percussion

Patient receives percussion therapy in the office on the day of follow up.

Group Type: EXPERIMENTAL

Massage Percussion Therapy device

Intervention Type: DEVICE

Using massage percussion postoperatively.

Both PACU and Postop appointment percussion.

Patient receives percussion therapy in the PACU and receives percussion therapy in the office on the day of follow up.

Group Type: EXPERIMENTAL

Massage Percussion Therapy device

Intervention Type: DEVICE

Using massage percussion postoperatively.

Interventions

Massage Percussion Therapy device

Using massage percussion postoperatively.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ryan Hsi

Urologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ryan Hsi

Role: PRINCIPAL_INVESTIGATOR

VUMC

Locations

University of Montreal

Montreal, , Canada

Countries

Canada

Other Identifiers

VUMC01

Identifier Type: -

Identifier Source: org_study_id