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Completed

NCT Number: NCT01852669

Adjunct Inversion for Lower Pole 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.

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Key information

Conditions

Kidney Stone Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Inversion

Procedure

Patients inverted 30 degree head down in Trendelenburg position

Shock Wave Lithotripsy

Procedure

Shock wave lithotripsy

Other names: ESWL

Hydration

Drug

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

Other names: Frusemide 20mg

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Monash University

Other

Collaborators

  • Lam Wah Ee Hospital

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
May 14, 2013
Registry last updated
Apr 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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