NCT01852669

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2002

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 14, 2013

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

April 20, 2015

Completed
Last Updated

April 20, 2015

Status Verified

April 1, 2015

Enrollment Period

6.9 years

First QC Date

May 2, 2013

Results QC Date

April 6, 2015

Last Update Submit

April 17, 2015

Conditions

Kidney Stone

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Inversion, Hydration, ESWL

EXPERIMENTAL

ESWL with hydration and inversion

Procedure: InversionProcedure: Shock Wave LithotripsyDrug: Hydration

ESWL, Hydration

ACTIVE COMPARATOR

ESWL with hydration

Procedure: Shock Wave LithotripsyDrug: Hydration

Interventions

InversionPROCEDURE

Patients inverted 30 degree head down in Trendelenburg position

Inversion, Hydration, ESWL
Shock Wave LithotripsyPROCEDURE

Shock wave lithotripsy

Also known as: ESWL
ESWL, HydrationInversion, Hydration, ESWL
HydrationDRUG

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

Also known as: Frusemide 20mg
ESWL, HydrationInversion, Hydration, ESWL

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Solitary lower pole caliceal stone which is \> 5 mm and \< 20mm
  • Not contraindicated for intravenous urogram (IVU) and subsequent X-rays
  • Patient able to comply strictly with visits/medications
  • Patient willing and agrees to enter study

You may not qualify if:

  • Impaired function of the affected kidney
  • Gross hydronephrosis of the affected kidney
  • Associated distal obstruction
  • Multiple stones
  • Stone more than 2 cm in size
  • Diverticular stone
  • Patients who are contraindicated for extracorporeal shockwave lithotripsy e.g.: Pregnancy
  • Patients who are unable to tolerate the procedure
  • Significant cardiac condition that does not allow the administration of force hydration or inversion.
  • Uncontrolled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Leong WS, Liong ML, Liong YV, Wu DB, Lee SW. Does simultaneous inversion during extracorporeal shock wave lithotripsy improve stone clearance: a long-term, prospective, single-blind, randomized controlled study. Urology. 2014 Jan;83(1):40-4. doi: 10.1016/j.urology.2013.08.004. Epub 2013 Sep 14.

    PMID: 24044912DERIVED

MeSH Terms

Conditions

Kidney Calculi

Interventions

Furosemide

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfanilamidesSulfonamidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur Compounds

Results Point of Contact

Title
Dr Shaun Lee
Organization
Monash University
shaun.lee@monash.edu
55145890

Study Officials

  • Liong Men Long, MBBS

    Lam Wah Ee Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

May 2, 2013

First Posted

May 14, 2013

Study Start

January 1, 2002

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

April 20, 2015

Results First Posted

April 20, 2015

Record last verified: 2015-04