Back to resultsAdjunct Inversion for Lower Pole Stone
Primary Purpose
Kidney Stone
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inversion
Shock Wave Lithotripsy
Hydration
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Stone
Eligibility Criteria
Inclusion Criteria:
- Solitary lower pole caliceal stone which is > 5 mm and < 20mm
- Not contraindicated for intravenous urogram (IVU) and subsequent X-rays
- Patient able to comply strictly with visits/medications
- Patient willing and agrees to enter study
Exclusion Criteria:
- Impaired function of the affected kidney
- Gross hydronephrosis of the affected kidney
- Associated distal obstruction
- Multiple stones
- Stone more than 2 cm in size
- Diverticular stone
- Patients who are contraindicated for extracorporeal shockwave lithotripsy e.g.: Pregnancy
- Patients who are unable to tolerate the procedure
- Significant cardiac condition that does not allow the administration of force hydration or inversion.
- Uncontrolled hypertension
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Inversion, Hydration, ESWL
ESWL, Hydration
Arm Description
ESWL with hydration and inversion
ESWL with hydration
Outcomes
Primary Outcome Measures
Number of Participants Who Are Stone Free at 3 Months
To compare the effectiveness of simultaneous adjunct controlled inversion therapy during extracorporeal shockwave lithotripsy (ESWL) to that of ESWL alone in the treatment of lower pole caliceal stone as measured by stone-free rate(SFR)
Secondary Outcome Measures
Full Information
NCT ID
NCT01852669
First Posted
May 2, 2013
Last Updated
April 17, 2015
Sponsor
Monash University
Collaborators
Lam Wah Ee Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01852669
Brief Title
Adjunct Inversion for Lower Pole Stone
Official Title
A Prospective, Randomized, Double Blind, Controlled Study Comparing Extracorporeal Shock Wave Lithotripsy (ESWL) With and Without Simultaneous Adjunct Controlled Inversion Therapy in the Treatment of Lower Pole Caliceal Stone
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Monash University
Collaborators
Lam Wah Ee Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a randomized controlled trial comparing extracorporeal shockwave lithotripsy (ESWL) with and without simultaneous adjunct controlled inversion therapy in the treatment of lower pole caliceal stone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inversion, Hydration, ESWL
Arm Type
Experimental
Arm Description
ESWL with hydration and inversion
Arm Title
ESWL, Hydration
Arm Type
Active Comparator
Arm Description
ESWL with hydration
Intervention Type
Procedure
Intervention Name(s)
Inversion
Intervention Description
Patients inverted 30 degree head down in Trendelenburg position
Intervention Type
Procedure
Intervention Name(s)
Shock Wave Lithotripsy
Other Intervention Name(s)
ESWL
Intervention Description
Shock wave lithotripsy
Intervention Type
Drug
Intervention Name(s)
Hydration
Other Intervention Name(s)
Frusemide 20mg
Intervention Description
Hydration of patient with 0.5L NaCl and 20mg frusemide IV
Primary Outcome Measure Information:
Title
Number of Participants Who Are Stone Free at 3 Months
Description
To compare the effectiveness of simultaneous adjunct controlled inversion therapy during extracorporeal shockwave lithotripsy (ESWL) to that of ESWL alone in the treatment of lower pole caliceal stone as measured by stone-free rate(SFR)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Solitary lower pole caliceal stone which is > 5 mm and < 20mm
Not contraindicated for intravenous urogram (IVU) and subsequent X-rays
Patient able to comply strictly with visits/medications
Patient willing and agrees to enter study
Exclusion Criteria:
Impaired function of the affected kidney
Gross hydronephrosis of the affected kidney
Associated distal obstruction
Multiple stones
Stone more than 2 cm in size
Diverticular stone
Patients who are contraindicated for extracorporeal shockwave lithotripsy e.g.: Pregnancy
Patients who are unable to tolerate the procedure
Significant cardiac condition that does not allow the administration of force hydration or inversion.
Uncontrolled hypertension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liong Men Long, MBBS
Organizational Affiliation
Lam Wah Ee Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
24044912
Citation
Leong WS, Liong ML, Liong YV, Wu DB, Lee SW. Does simultaneous inversion during extracorporeal shock wave lithotripsy improve stone clearance: a long-term, prospective, single-blind, randomized controlled study. Urology. 2014 Jan;83(1):40-4. doi: 10.1016/j.urology.2013.08.004. Epub 2013 Sep 14.
Results Reference
derived
Learn more about this trial
Adjunct Inversion for Lower Pole Stone
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