Shock wave Lithotripsy And mechanical Percussion therapy for lower pole renal calculi (SLAP) trial.

Not Applicable

• Conditions: Renal calculi; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12616000336482
• Lead Sponsor: Jay Roberts

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Participants will have lower pole stones 5-15mm who are already scheduled to receive ESWL independent of this trial. Participants will be identified for the trial only after they have been assessed based on standard clinical practice to be suitable for ESWL.

Exclusion Criteria

1.Anatomical abnormalities including horseshoe kidney, fragments in calyceal diverticulum, infundibular stenosis, pelvo-ureteric junction obstruction, or ureteric stricture
2.Contraindications to ESWL including abdominal aortic aneurysm, anticoagulant or antiplatelet treatment unable to be safely stopped peri-ESWL.
3.Radiolucent calculi including uric acid stones
4.Presence of ureteric stent
5.Medical conditions which might make inversion dangerous including morbid obesity, uncontrolled hypertension, previous cerebrovascular accident, significant coronary artery disease, symptomatic gastro-oesophageal reflux
6.Previous treatment for same stone within last three months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stone free status as assessed by plain X-ray kidney/ureter/bladder (KUB). This will be reviewed by a blinded, independent reviewer.[Three months following final ESWL session. For those in the crossover group, final timepoint will be three months from commencement percussion therapy.]

Secondary Outcome Measures

Name	Time	Method
Complication rates - complications of ESWL include haematuria (common), infection, renal or ureteric obstruction (Steinstrasse), perinephric haematoma, retained stone fragments. These will be assessed by interview with completion proforma at each 4 week review, which includes an x-ray KUB.<br><br>There are no known complications of percussion therapy other than mild discomfort.[Complications will be assessed at each four week review following ESWL. For those in the crossover group, complications will continued to be assessed at each four week review until three months from the commencement of percussion therapy.]