Massage Percussion for Passage of Urolithiasis Fragments After Ureteroscopy.

NCT05872230 | Terminated

• 1 other identifier: VUMC01
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Nephrolithiasis

Outcome Measures

Primary Outcomes (2)

• Patients who are able to tolerate and complete the percussion therapy.

  If patients can tolerate the percussion therapy in the treatment arms. This is evaluated by patients being able to complete the percussion therapy session and completing pain questionnaires.

  Postop day 0-10.

• Stone Free Rate.

  Patients will have standard postoperative imaging at six weeks, as is standard of care. Presence of stone fragments and fragment size will determine the postoperative stone free rate.

  6 weeks after surgery.

Secondary Outcomes (2)

• weight of passed stone fragments

  6 weeks.

• Unplanned return visits.

  6 weeks.

Study Arms (4)

Control

NO INTERVENTION

Patient receives standard postoperative care with no percussion therapy.

PACU percussion

EXPERIMENTAL

Patient receives percussion therapy in the PACU immediately after surgery.

Device: Massage Percussion Therapy device

Postoperative appointment percussion

EXPERIMENTAL

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

Device: Massage Percussion Therapy device

Both PACU and Postop appointment percussion.

EXPERIMENTAL

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

Device: Massage Percussion Therapy device

Interventions

Massage Percussion Therapy device DEVICE

Using massage percussion postoperatively.

Both PACU and Postop appointment percussion.; PACU percussion; Postoperative appointment percussion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

University of Montreal

Montreal, Canada

Location

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Study Officials

• Ryan Hsi

  VUMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urologist

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 24, 2023
• Study Start: February 1, 2024
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)