PUrE: percutaneous nephrolithotomy, flexible ureterorenoscopy and extracorporeal shockwave lithotripsy for lower pole kidney stones

Not Applicable

Completed

• Conditions: ower pole kidney stones; Urological and Genital Diseases

• Registration Number: ISRCTN98970319
• Lead Sponsor: niversity of Aberdeen (UK)

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32498699/ protocol (added 08/06/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-11
• Study Completion: 2023-02-28
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 625

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).<br>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).