Adjunct Inversion for Lower Pole Stone

Monash University

Status: Completed

Conditions: Kidney Stone

Treatments: Procedure: Shock Wave Lithotripsy; Procedure: Inversion; Drug: Hydration

Study type: Interventional

Funder types: Other

Identifiers

NCT01852669

LPS001

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups

Inversion, Hydration, ESWL

Experimental group

Description:

ESWL with hydration and inversion

Treatment:

Procedure: Inversion

Drug: Hydration

Procedure: Shock Wave Lithotripsy

ESWL, Hydration

Active Comparator group

Description:

ESWL with hydration

Treatment:

Drug: Hydration

Procedure: Shock Wave Lithotripsy