Adjunct Inversion for Lower Pole Stone

Kidney Stone Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01852669
• Other study ID #: LPS001
• Status: Completed
• Phase: N/A
• First received: May 2, 2013
• Last updated: April 17, 2015
• Start date: January 2002
• Est. completion date: December 2008

Study information

• Verified date: April 2015
• Source: Monash University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone
• Nephrolithiasis

Intervention

Procedure:
• Inversion
Patients inverted 30 degree head down in Trendelenburg position
• Shock Wave Lithotripsy
Shock wave lithotripsy

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Monash University	Lam Wah Ee Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	3 months	No