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Massage Percussion for Passage of Urolithiasis Fragments After Ureteroscopy.

Primary Purpose

Nephrolithiasis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Massage Percussion Therapy device
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nephrolithiasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Montreal

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control

PACU percussion

Postoperative appointment percussion

Both PACU and Postop appointment percussion.

Arm Description

Patient receives standard postoperative care with no percussion therapy.

Patient receives percussion therapy in the PACU immediately after surgery.

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

weight of passed stone fragments
PAtients will strain urine to collect stone fragments after surgery until stent removal. The stone fragments will be sent for stone analysis, as is standard of care, during which fragments will be weighed.
Unplanned return visits.
Follow patients who have unplanned return trips to the ED or the clinic for pain or complications after surgery.

Full Information

First Posted
May 4, 2023
Last Updated
August 12, 2023
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05872230
Brief Title
Massage Percussion for Passage of Urolithiasis Fragments After Ureteroscopy.
Official Title
Massage Percussion Therapy for Passage of Urolithiasis Fragments After Ureteroscopy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrolithiasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Patient receives standard postoperative care with no percussion therapy.
Arm Title
PACU percussion
Arm Type
Experimental
Arm Description
Patient receives percussion therapy in the PACU immediately after surgery.
Arm Title
Postoperative appointment percussion
Arm Type
Experimental
Arm Description
Patient receives percussion therapy in the office on the day of follow up.
Arm Title
Both PACU and Postop appointment percussion.
Arm Type
Experimental
Arm Description
Patient receives percussion therapy in the PACU and receives percussion therapy in the office on the day of follow up.
Intervention Type
Device
Intervention Name(s)
Massage Percussion Therapy device
Intervention Description
Using massage percussion postoperatively.
Primary Outcome Measure Information:
Title
Patients who are able to tolerate and complete the percussion therapy.
Description
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.
Time Frame
Postop day 0-10.
Title
Stone Free Rate.
Description
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.
Time Frame
6 weeks after surgery.
Secondary Outcome Measure Information:
Title
weight of passed stone fragments
Description
PAtients will strain urine to collect stone fragments after surgery until stent removal. The stone fragments will be sent for stone analysis, as is standard of care, during which fragments will be weighed.
Time Frame
6 weeks.
Title
Unplanned return visits.
Description
Follow patients who have unplanned return trips to the ED or the clinic for pain or complications after surgery.
Time Frame
6 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan Hsi
Phone
615-343-2036
Email
ryan.hsi@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Hsi
Organizational Affiliation
VUMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Montreal
City
Montréal
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naeem Bhojani

12. IPD Sharing Statement

Plan to Share IPD
No

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Massage Percussion for Passage of Urolithiasis Fragments After Ureteroscopy.

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