Spontaneous Urinary Stone Passage ENabled by Drugs

Phase 3

Completed

Conditions: Symptomatic Ureteric Stones
Urological and Genital Diseases
Calculus of kidney and ureter

Registration Number: ISRCTN69423238

Lead Sponsor: niversity of Aberdeen (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 1200

Inclusion Criteria

1. Patients presenting acutely with ureteric colic
2. Adults =18 = 65 years of age
3. Presence of stone confirmed by non-contrast computed tomography of the kidney, ureter and bladder (CTKUB), or by intravenous urogram (IVU) with subsequent CTKUB confirmation within 12 hours
4. Stone within any segment of the ureter
5. Unilateral ureteric stone
6. Largest stone dimension =10 mm
7. Female subjects must be post menopausal (defined as 12 months with no menses without an alternative medical cause), permanently sterilised or willing to use two methods of contraception listed in the protocol prior to the start of dosing until at least 28 days after receiving the last dose of trial medication
8. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form

Exclusion Criteria

1. Women who have a known or suspected pregnancy
2. Women who are breastfeeding
3. Asymptomatic incidentally found ureteric stone
4. Stone not confirmed by CTKUB
5. Stone with any one dimension >10 mm
6. Kidney stone without the presence of ureteric stone
7. Multiple (i.e. = 2) stones within ureter
8. Bilateral ureteric stones
9. Stone in a ureter draining a solitary kidney (either anatomically or functionally)
10. Patients with abnormal renal tract anatomy (such as a duplex system, horseshoe kidney or ileal conduit)
11. Presence of urinary sepsis
12. Chronic renal failure (estinated Glomerular Filtration Rate [eGFR] < 30ml/min)
13. Patients currently taking an a blocker
14. Patients currently taking a calcium channel blocker
15. Patients currently taking PDE5 inhibitors
16. Contraindication or allergy to tamsulosin or nifedipine
17. Patients who are unable to understand or complete trial documentation

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Spontaneous passage of ureteric stones at four weeks (defined as no further intervention required to facilitate stone passage)<br>2. Incremental cost per quality adjusted life years (QALYs) gained at 12 weeks. QALYs are based on the responses to the EQ-5D.

Secondary Outcome Measures

Name	Time	Method
1. Patient-reported outcomes, at baseline, 4 and 12 weeks:<br>1.1. Severity of pain as measured by Verbal descriptor scale (VDS) and Numeric Rating scale (NRS)<br>1.2. Generic health profile as measured by the SF 36 and use of analgesia<br>2. Clinical outcomes:<br>2.1. Time to passage of stone<br>2.2. Further interventions received at 12 weeks<br>3. Safety: Patient reported discontinuation of trial medications<br>4. Cost effectiveness: <br>4.1. NHS primary and secondary care use and costs up to three months, incremental cost per surgical interventions averted<br>4.2. Modelled incremental cost per QALY beyond the 12 week trial follow-up