Adjunct Inversion for Lower Pole Stone

Not Applicable

Completed

• Conditions: Kidney Stone
• Interventions: Procedure: Inversion; Procedure: Shock Wave Lithotripsy; Drug: Hydration

• Registration Number: NCT01852669
• Lead Sponsor: Monash University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-01
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2013-05-02
• Study First Submitted QC: 2013-05-13
• Study First Posted: 2013-05-14
• Status Verified: 2015-04
• Results First Submitted: 2015-04-06
• Results First Submitted QC: 2015-04-17
• Last Update Submitted: 2015-04-17
• Results First Posted: 2015-04-20
• Last Update Posted: 2015-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inversion, Hydration, ESWL	Hydration	ESWL with hydration and inversion
ESWL, Hydration	Hydration	ESWL with hydration
Inversion, Hydration, ESWL	Inversion	ESWL with hydration and inversion
Inversion, Hydration, ESWL	Shock Wave Lithotripsy	ESWL with hydration and inversion
ESWL, Hydration	Shock Wave Lithotripsy	ESWL with hydration

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Are Stone Free at 3 Months	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)