Adjunct Inversion for Lower Pole Stone

Monash University140 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

140

Conditions

Kidney Stone

Interventions

InversionPROCEDURE

Patients inverted 30 degree head down in Trendelenburg position

Shock Wave LithotripsyPROCEDURE

Shock wave lithotripsy

HydrationDRUG

Hydration of patient with 0.5L NaCl and 20mg frusemide IV

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Solitary lower pole caliceal stone which is \> 5 mm and \< 20mm 2. Not contraindicated for intravenous urogram (IVU) and subsequent X-rays 3. Patient able to comply strictly with visits/medications 4. Patient willing and agrees to enter study Exclusion Criteria: 1. Impaired function of the affected kidney 2. Gross hydronephrosis of the affected kidney 3. Associated distal obstruction 4. Multiple stones 5. Stone more than 2 cm in size 6. Diverticular stone 7. Patients who are contraindicated for extracorporeal shockwave lithotripsy e.g.: Pregnancy 8. Patients who are unable to tolerate the procedure 9. Significant cardiac condition that does not allow the administration of force hydration or inversion. 10. Uncontrolled hypertension

Outcomes

Primary Outcomes

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)

Time frame: 3 months

Data from ClinicalTrials.gov

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