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
Overview
- Phase
- Not Applicable
- Intervention
- Hydration
- Conditions
- Kidney Stone
- Sponsor
- Monash University
- Enrollment
- 140
- Primary Endpoint
- Number of Participants Who Are Stone Free at 3 Months
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Shaun Lee Wen Huey
Senior Lecturer
Monash University
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
Arms & Interventions
ESWL, Hydration
ESWL with hydration
Intervention: Hydration
Inversion, Hydration, ESWL
ESWL with hydration and inversion
Intervention: Inversion
Inversion, Hydration, ESWL
ESWL with hydration and inversion
Intervention: Shock Wave Lithotripsy
Inversion, Hydration, ESWL
ESWL with hydration and inversion
Intervention: Hydration
ESWL, Hydration
ESWL with hydration
Intervention: Shock Wave Lithotripsy
Outcomes
Primary Outcomes
Number of Participants Who Are Stone Free at 3 Months
Time Frame: 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)