Therapeutic interventions for stones of the ureter

Conditions

Ureteric stone treatment Urological and Genital Diseases Ureteric stone

Ranan Dasgupta, Sarah Cameron, Lorna Aucott, Graeme MacLennan, Mary M Kilonzo et al. (17 authors)

Health Technology Assessment2022-03-015 citations

10.3310/wuzw9042

Disposable versus Reusable Ureteroscopes: A Prospective Multicenter Randomized Comparison

Giorgio Bozzini, B. Filippi, Sulieman Alriyalat, Alberto Calori, Umberto Besana et al. (13 authors)

Research and Reports in Urology2021-02-0119 citations

10.2147/rru.s277049

TISU: Extracorporeal shockwave lithotripsy, as first treatment option, compared with direct progression to ureteroscopic treatment, for ureteric stones: study protocol for a randomised controlled trial.

McClinton S, Cameron S, Starr K, Thomas R, MacLennan G, McDonald A, Lam T, N'Dow J, Kilonzo M, Pickard R, Anson K, Keeley F, Burgess N, Clark CT, MacLennan S, Norrie J, TISU Study Group.

2018-05-2212 citations

10.1186/s13063-018-2652-1

Interventions

Participants will be randomly allocated to either ESWL or ureteroscopy. Extracorporeal shockwave lithotripsy (ESWL) involves generation of a shock-wave, external to the body, focused

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The study has a primary clinical and a primary economic outcome reflecting the multidimensional nature of the possible effects the intervention may have. Clinical: Clearance of ureteric stones operationally defined as ?no further intervention required to facilitate stone clearance? up to 6 months from randomisation. 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.	—

Measure

Time frame

The study has a primary clinical and a primary economic outcome reflecting the multidimensional nature of the possible effects the intervention may have. Clinical: Clearance of ureteric stones operationally defined as ?no further intervention required to facilitate stone clearance? up to 6 months from randomisation. 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.

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Secondary

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

Measure

Time frame

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

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Countries

Scotland, United Kingdom

Outcome results

None listed