Evaluation of Tamsulosin in the Treatment of Ureteral Stones

Ureteral Calculi Clinical Trial

— TAMSULOSINE  

Official title:

Interest of a Treatment With the alpha1-blocker Tamsulosin in the Elimination of Pelvis Ureteral Stones

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00151567
• Other study ID #: AFSSAPS 010751
• Secondary ID: PHRC/00-01CIC020
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: December 3, 2012
• Start date: February 2002
• Est. completion date: December 2006

Study information

• Verified date: September 2008
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

Ureteral stones have an important place in daily urological practice, usually causing acute episodes of ureteral colic by obstructing the urinary tract. The aim of the study is to evaluate whether repeated administration of tamsulosin, a drug routinely used in the treatment of lower urinary tract symptoms, could lower the delay of elimination of the stone in patients with pelvis ureterolithiasis.

Description:

Ureteral colic, mainly due to ureterolithiasis, represents 1 to 2% of hospital emergency admissions. When a surgical intervention is not required, usual treatment combines hydration and anti-inflammatory drugs.

Alpha1-blockers, firstly developed as anti-hypertensive drugs, are now also used in the management of benign prostatic hyperplasia, due to their relaxing properties on the urinary tract. The aim of the study is to investigate whether tamsulosin could lower the delay of elimination of the stone in patients with pelvis ureterolithiasis. Patients are randomized to receive either tamsulosin or a placebo in addition to usual treatment until stone elimination. Efficacy is assessed by evaluating the time to spontaneous passage of the stone between day 1 and day 42, the need for surgery and pain recurrences.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult over 18 years

• Emergency admission for a ureteral colic

• Radio-opaque ureterolithiasis

• Stone of 2 to 7 mm diameter

• Informed written consent

Exclusion Criteria:

• Pregnancy or breast-feeding

• Treatment with alpha or beta-blocker

• Contraindication to tamsulosin (orthostatic hypertension, hepatic failure)

• Complication needing surgery

• Calculi spontaneous passage before randomization

• Patient not available for a 6 week follow-up

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ureteral Calculi
• Ureterolithiasis

Intervention

Drug:
• Tamsulosin
Oral tamsulosin once a day until stone elimination or the end of the follow-up (42 days)
• Placebo
Oral placebo of tamsulosin once a day until stone elimination or the end of the follow-up (42 days)

Locations

Country	Name	City	State
France	Service d'Urologie- Hôpital du Val de Grâce	Paris
France	Service d'Urologie - Hôpital de La Milétrie	Poitiers
France	Hôpital de Redon	Redon
France	Service d'Urologie- Hôpital Robert Debré	Reims
France	Service d'Urologie- Hôpital Pontchaillou	Rennes
France	Service d'Urologie - Hôpital Bretonneau	Tours

Sponsors (3)

Lead Sponsor	Collaborator
Rennes University Hospital	Ministry of Health, France, Yamanouchi

Country where clinical trial is conducted

France, 

References & Publications (2)

Resim S, Ekerbicer H, Ciftci A. Effect of tamsulosin on the number and intensity of ureteral colic in patients with lower ureteral calculus. Int J Urol. 2005 Jul;12(7):615-20. — View Citation

Wilde MI, McTavish D. Tamsulosin. A review of its pharmacological properties and therapeutic potential in the management of symptomatic benign prostatic hyperplasia. Drugs. 1996 Dec;52(6):883-98. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to stone elimination in days (censored criterion)		between day 1 and 42	No
Secondary	Time to stone elimination in days in patients with spontaneous elimination (quantitative criterion)		between day 1 and 42	No
Secondary	Pain using Visual Analogue Scale		days 1, 2, 3	No
Secondary	Spontaneous stone elimination rate		days 1, 7, 14, 21, 28, 35, and 42	No
Secondary	Spontaneous stone elimination rate, according to stone size (2-3 mm, 4-5 mm, 6-7 mm)		days 1, 7, 14, 21, 28, 35, and 42	No
Secondary	Rate of need for surgery		Within 42 days	No
Secondary	Time to surgery in days in patients with surgical elimination		between day 1 and day 42	No
Secondary	Rate of pain recurrences		within 42 days	No
Secondary	Time to the first recurrence in days		between day 1 and day 42	No
Secondary	Rate of need for corticoids or morphine		Within 42 days	No
Secondary	Time to the first administration of corticoids or morphine in days		between day 1 and day 42	No
Secondary	Rate of adverse events		Within 42 days	Yes