Observational Approach Versus Surgical Intervention for Stones
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6+
SponsorChildren's Hospital of Philadelphia
About this trial
The aims of the Observational Approach versus Surgical Intervention for Asymptomatic Stone (OASIS) trial are: 1) to determine whether observation compared to upfront surgery results in less healthcare-related life disruption due to kidney stones among children and adults with asymptomatic kidney stones; 2) to identify the groups benefiting the most from each strategy; and 3) to determine the preferences and values informing the choice between observation and upfront surgery.
Eligibility criteria
Qualifiers
Individuals age 6 or older
Diagnosis of kidney stone disease (nephrolithiasis)
Asymptomatic, non-obstructive kidney stones measuring 4 to 10 mm (inclusive)
Asymptomatic is defined as the absence of abdominal pain, flank pain, gross hematuria, and nausea and/or vomiting in the last 3 months that in the judgement of the site PI could be attributable to kidney stones.
Disqualifiers
Untreated hydronephrosis or caliectasis
Pain (e.g., renal colic, abdominal pain) or gross hematuria attributed to kidney stones.
Recurrent symptomatic urinary tract infections (≥3 in 12 months or ≥2 in 6 months). A symptomatic urinary tract infection is defined as having at least one bladder or voiding symptom (e.g., frequency, urgency, dysuria) with bacteriuria (≥105 colony forming units/mL of no more than 2 urinary tract pathogens).
Stone in the renal pelvis, ureter, bladder or urethra
Trial design
Treatments tested in this trial
- Surgery
- Observation
Treatment groups
1,658 Participants
are divided into 2 treatment groupsSponsors and collaborators
Children's Hospital of Philadelphia
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov