Use of Alfuzosin in Stone Treatment With ESWL

NCT00388271 | Withdrawn Phase 3

• 1 other identifier: SGH/URO/XTR001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Urinary tract stones may form in the kidneys or along the ureteric tracts and when left untreated, may result in complications such as pain, bleeding, infection and obstruction. ESWL (extra-corporeal shock wave lithotripsy) has been shown to be an effective and safe method of treatment for kidney and ureteric stones in-situ. In our centre, ESWL is done on an outpatient basis with oral pain killers in the weeks following treatment. Patients are also instructed to increase their fluid intake during this period to expedite the clearance of stone fragments. There have been studies to show that pain caused by stones is due to smooth muscle spasm along the ureters, possibly mediated by alpha-receptors. Alpha-blockers have been shown to improve the expulsion of stones and also improve pain relief when used alone, or together with ESWL treatment. In our study, we seek to investigate if alpha-blocker therapy (Alfuzosin) increases stone free rates and improves pain control after ESWL for renal and ureteric stones. The potential benefits include a higher rate of stone clearance and better pain control

Conditions

Urinary Calculi

Keywords

Alpha-blocker; Alfuzosin; Xatral; ESWL

Outcome Measures

Primary Outcomes (3)

• Reduction in pain score

  1 month

• Reduction in use of analgesics

  1 month

• stone free rate

  1 month

Secondary Outcomes (1)

• Severe giddiness as a side-effect

  1 month

Study Arms (2)

1

ACTIVE COMPARATOR

xatral

Drug: Alfuzosin (Xatral)

2

PLACEBO COMPARATOR

standard treatment

Drug: standard treatment

Interventions

Alfuzosin (Xatral) DRUG

standard treatment plus alfuzosin

1

standard treatment DRUG

standard treatment

2

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients referred to our centre for ESWL treatment of renal or ureteric stones who give their informed consent.

You may not qualify if:

• Documented allergy or severe side effects to opioids/ NSAIDs/ Alfuzosin Severe hydronephrosis (on ultrasound or IVU) Radiolucent stones Urinary tract infections Previous pyeloureteral surgery Lower pole stones DJ stents in situ for stones Known renal/hepatic impairment or coagulopathy Pregnant Severe skeletal disease

Sponsors & Collaborators

• Singapore General Hospital: lead
• Sanofi: collaborator

Study Sites (1)

Urology Centre

Singapore, Singapore

Location

Related Publications (1)

• Gravina GL, Costa AM, Ronchi P, Galatioto GP, Angelucci A, Castellani D, Narcisi F, Vicentini C. Tamsulosin treatment increases clinical success rate of single extracorporeal shock wave lithotripsy of renal stones. Urology. 2005 Jul;66(1):24-8. doi: 10.1016/j.urology.2005.01.013.

  PMID: 15992885 BACKGROUND

MeSH Terms

Conditions

Urinary Calculi

Interventions

alfuzosin

Condition Hierarchy (Ancestors)

Urolithiasis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Tsung Wen Chong, MBBS, FRCS

  SGH Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2006
• First Posted: October 16, 2006
• Study Start: October 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: February 10, 2017

Record last verified: 2017-02

Locations

SG (1)