Comparing the effect of alpha-blocker versus observation on stone passage following shockwave lithotripsy treatment for renal or ureteric stones.

Phase 3

• Conditions: rolithiasis; Urolithiasis; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12616001718437
• Lead Sponsor: Department of Urology, Case Hospital, Monash Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 314

Inclusion Criteria

1) Patients presented for and completed shockwave lithotripsy treatment for renal or ureteric stones.
2) Patient must be eligible for fluoroscopic guided shockwave lithotripsy with no contraindications
3) Adults between 18 and 80 years of age (inclusive)
4) Presence of stone confirmed by computed tomography of the kidney, ureter and bladder
5) Capable of giving written informed consent, which includes compliance with the requirements of the trial

Exclusion Criteria

1) Women who are breastfeeding
2) Patients currently taking an a-blocker
3) Patients currently taking PDE5 inhibitors
4) Contraindication or allergy to tamsulosin
5) Patient who are unable to understand or complete trial documentation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stone passage rate assessed using a low-dose computed tomography kidney, ureter and bladder at 6 weeks following shockwave lithotripsy[6 weeks following shockwave lithotripsy]

Secondary Outcome Measures

Name	Time	Method
Pain associated with stone passage using a visual analogue scale at day 7 and 6 weeks following shockwave lithotripsy.[7 days following shockwave lithotripsy, and 6 weeks following shockwave lithotripsy];Analgesic requirement for the first 7 days following shockwave lithotripsy using a patient questionnaire.<br>The questionnaire is specifically designed for this study and asks patient to report the number of tablets of simple analgesia used and the number of tablets of opioid analgesia used.[7 days following shockwave lithotripsy];Economic burden associated with stone episode calculated by number of days off work[6 weeks following shockwave lithotripsy]