TAMSULOSINE: Evaluation of Tamsulosin in the Treatment of Ureteral Stones

Sponsor

Rennes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00151567

Collaborator

Ministry of Health, France (Other), Yamanouchi (Other)

129

Enrollment

Locations

Arms

Duration (Months)

21.5

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Ureterolithiasis Ureteral Calculi	Drug: Tamsulosin Drug: Placebo	Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

129 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2002

Actual Primary Completion Date :

Dec 1, 2006

Actual Study Completion Date :

Dec 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Tamsulosin	Drug: Tamsulosin Oral tamsulosin once a day until stone elimination or the end of the follow-up (42 days)
Placebo Comparator: 2 Placebo	Drug: Placebo Oral placebo of tamsulosin once a day until stone elimination or the end of the follow-up (42 days)

Arm

Intervention/Treatment

Experimental: 1

Tamsulosin

Drug: Tamsulosin

Oral tamsulosin once a day until stone elimination or the end of the follow-up (42 days)

Placebo Comparator: 2

Placebo

Drug: Placebo

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

Outcome Measures

Primary Outcome Measures

Time to stone elimination in days (censored criterion) [between day 1 and 42]

Secondary Outcome Measures

Time to stone elimination in days in patients with spontaneous elimination (quantitative criterion) [between day 1 and 42]
Pain using Visual Analogue Scale [days 1, 2, 3]
Spontaneous stone elimination rate [days 1, 7, 14, 21, 28, 35, and 42]
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]
Rate of need for surgery [Within 42 days]
Time to surgery in days in patients with surgical elimination [between day 1 and day 42]
Rate of pain recurrences [within 42 days]
Time to the first recurrence in days [between day 1 and day 42]
Rate of need for corticoids or morphine [Within 42 days]
Time to the first administration of corticoids or morphine in days [between day 1 and day 42]
Rate of adverse events [Within 42 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Service d'Urologie- Hôpital du Val de Grâce	Paris	France	75005
2	Service d'Urologie - Hôpital de La Milétrie	Poitiers	France	86021
3	Hôpital de Redon	Redon	France	35600
4	Service d'Urologie- Hôpital Robert Debré	Reims	France	51092
5	Service d'Urologie- Hôpital Pontchaillou	Rennes	France	35033
6	Service d'Urologie - Hôpital Bretonneau	Tours	France	37044