N/A
N=140
Adjunct Inversion for Lower Pole Stone
Kidney Stone
Bottom Line
View on ClinicalTrials.gov: NCT01852669 ↗Enrolled (actual)
140
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Number of Participants Who Are Stone Free at 3 Months — 54; 49 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Inversion (Procedure); Shock Wave Lithotripsy (Procedure); Hydration (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Monash University
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Are Stone Free at 3 Months |
54; 49 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01852669). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.