Lower pole kidney stones Urological and Genital Diseases
Conditions
Interventions
RCT 1: FURS versus ESWL for stone sizes 10mm <=25 mm
FURS
A flexible ureteroscope is passed into the kidney and a holmium laser fibre used to fragment stones. Stone fragments are then either retrieve
Sponsors
University of Aberdeen (UK)
Grampian Health Board (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults =16 years of age 2. Lower pole stone =25 mm in maximum dimension with decision to treat that stone 3. Presence of stone confirmed by CTKUB 4. Able and willing to undergo either treatment for specified stone size 5. Capacity to give informed consent to participate in trial which includes adherence to trial requirements
Exclusion criteria
Exclusion criteria: 1. Pregnancy 2. Patients with co-existing stone that takes precedence in deciding treatment modality (such as obstructing ureteric stone or large upper pole stone) 3. Patients with health or other factors that are absolute contraindications to an intervention that they may be allocated 4. Patients unable to understand or complete trial documentation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Patient-reported: Health status (EQ-5D-5L) area under the curve (AUC) to 12 weeks post intervention, based upon EQ-5D completion at fixed time points; at baseline (recruitment), just prior to initial intervention (FURS, PCNL or first session of ESWL), at 1, 2, 4, 8, and 12 weeks after initial intervention, and at variable time points; just prior and 1 week after any additional intervention (including planned additional ESWL sessions and removal of stent) and once during hospitalisation for adverse events related to treatment (e.g. pain and infection). 2. Economic: Incremental cost per quality adjusted life year (QALYs) gained at 12 months post-randomisation based on the estimated NHS costs and participant responses to the EQ-5D (including additional time point at 12 months). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient reported: 1.1. Severity of pain as measured by the Numeric Rating scale (NRS; completed with EQ-5D-5L) 1.2. Generic health profile as measured by the SF-12 (completed at baseline and 12 months) 1.3. Use of analgesia (completed with NRS and EQ-5D) 2. Clinical: 2.1. Stone clearance measured at between 8 and 12 weeks post initial intervention using renal imaging (CTKUB preferred but plain x-ray and ultrasound acceptable). Measured by local trial staff and categorized as complete, acceptable, or unacceptable. Also maximum dimension of the largest fragment of the treated stone in mm 2.2. Need for additional treatment (carried out or planned) at 12 weeks post-initial treatment and 12 months post randomisation 2.3. Complications during initial intervention. Intervention-related complications at 12 weeks (categorised by Clavien-Dindo classification) post treatment and up to 12 months post randomisation. All measured by site staff and entered on CRF. 3. Economic: 3.1. NHS primary and secondary care resources used and their costs 3.2. Patient costs (out of pocket), time off work up to 12 months post randomisation Data gathered from completion of CRFs by site staff and participant questionnaire at 12 weeks post initial treatment and 12 months post randomisation. | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactDawn McRae
Outcome results
None listed