Adjunct Inversion for Lower Pole Stone

April 17, 2015 updated by: Shaun Lee Wen Huey, Monash University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inversion, Hydration, ESWL
ESWL with hydration and inversion
Procedure: Inversion
Patients inverted 30 degree head down in Trendelenburg position
Procedure: Shock Wave Lithotripsy
Shock wave lithotripsy
Other Names:
  • ESWL
Drug: Hydration
Hydration of patient with 0.5L NaCl and 20mg frusemide IV
Other Names:
  • Frusemide 20mg
Active Comparator: ESWL, Hydration
ESWL with hydration
Procedure: Shock Wave Lithotripsy
Shock wave lithotripsy
Other Names:
  • ESWL
Drug: Hydration
Hydration of patient with 0.5L NaCl and 20mg frusemide IV
Other Names:
  • Frusemide 20mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Monash University

Collaborators

Lam Wah Ee Hospital

Investigators

  • Principal Investigator: Liong Men Long, MBBS, Lam Wah Ee Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

May 2, 2013

First Submitted That Met QC Criteria

May 13, 2013

First Posted (Estimate)

May 14, 2013

Study Record Updates

Last Update Posted (Estimate)

April 20, 2015

Last Update Submitted That Met QC Criteria

April 17, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LPS001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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