Therapeutic interventions for stones of the ureter

Not Applicable

Completed

• Conditions: reteric stone treatment; Urological and Genital Diseases; Ureteric stone

• Registration Number: ISRCTN92289221
• Lead Sponsor: niversity of Aberdeen

Brief Summary

2017 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/28801422 evaluation of recruitment processes 2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29788982 protocol 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33604311/ sub study results (added 22/02/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33810921/ (added 21/02/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35301982/ (added 21/03/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-21
• Study Completion: 2017-02-28
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 613

Inclusion Criteria

1. Presence of stone confirmed by Computed Tomography Scan of the Kidneys, Ureters and Bladder (CTKUB)
2. Patients with a ureteric stone requiring removal
3. Adults =16 years of age
4. Single ureteric stone requiring treatment
5. Suitable for either ESWL or ureteroscopic treatment
6. Capable of giving written informed consent, which includes adherence with the requirements of the trial.

Exclusion Criteria

1. Pregnancy
2. Stones not confirmed by CTKUB
3. Bilateral ureteric stone(s)
4. Patients with abnormal urinary tract anatomy (such as a horseshoe kidney or ileal conduit)
5. Patients unable to understand or complete trial documentation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> The study has a primary clinical and a primary economic outcome reflecting the multidimensional nature of the possible effects the intervention may have.<br><br> Clinical: Clearance of ureteric stones operationally defined as ?no further intervention required to facilitate stone clearance? up to 6 months from randomisation.<br><br> Economic: Incremental cost per quality adjusted life years (QALYs) gained at 6 months from randomisation. QALYs are based on the responses to the EQ-5D.<br>

Secondary Outcome Measures

Name	Time	Method
<br> Patient-reported, measured at pre and 1 week post intervention, 8 weeks and 6 months post randomisation:<br> 1. Severity of pain measured by the Numeric Rating scale (NRS)<br> 2. Generic health profile measured by the SF-12 (8 weeks and 6 months only)<br> 3. Health status measured by the EQ5D<br> 4. Use of analgesia<br> 5. Acceptability of received procedure (8 weeks and 6 months only)<br><br> Clinical: Further interventions received, complications up to 6 months post randomisation<br><br> Economic: NHS primary and secondary care use and costs up to 6 months, patient costs; incremental cost per surgical interventions averted.<br>