Kidney Stone
Conditions
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.
Interventions
PROCEDUREInversion
Patients inverted 30 degree head down in Trendelenburg position
PROCEDUREShock Wave Lithotripsy
Shock wave lithotripsy
DRUGHydration
Hydration of patient with 0.5L NaCl and 20mg frusemide IV
Sponsors
Lam Wah Ee Hospital
Monash University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Are Stone Free at 3 Months | 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) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Inversion, Hydration, ESWL ESWL with hydration and inversion
Inversion: Patients inverted 30 degree head down in Trendelenburg position
Shock Wave Lithotripsy: Shock wave lithotripsy
Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV | 71 |
| ESWL, Hydration ESWL with hydration
Shock Wave Lithotripsy: Shock wave lithotripsy
Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV | 68 |
| Total | 139 |
Baseline characteristics
| Characteristic | Inversion, Hydration, ESWL | ESWL, Hydration | Total |
|---|---|---|---|
| Age, Continuous | 48.3 years STANDARD_DEVIATION 11.1 | 50.9 years STANDARD_DEVIATION 12.9 | 49.63 years STANDARD_DEVIATION 12 |
| Sex: Female, Male Female | 20 Participants | 21 Participants | 41 Participants |
| Sex: Female, Male Male | 51 Participants | 47 Participants | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 71 | 2 / 68 |
| serious Total, serious adverse events | 0 / 71 | 0 / 68 |
Outcome results
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)
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Inversion, Hydration, ESWL | Number of Participants Who Are Stone Free at 3 Months | 54 participants |
| ESWL, Hydration | Number of Participants Who Are Stone Free at 3 Months | 49 participants |