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Evaluation of Tamsulosin in the Treatment of Ureteral Stones (TAMSULOSINE)

Primary Purpose

Ureterolithiasis, Ureteral Calculi

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Tamsulosin
Placebo
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ureterolithiasis focused on measuring Ureterolithiasis, Alpha1-blocker, Lower ureteral stone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Service d'Urologie- Hôpital du Val de Grâce
  • Service d'Urologie - Hôpital de La Milétrie
  • Hôpital de Redon
  • Service d'Urologie- Hôpital Robert Debré
  • Service d'Urologie- Hôpital Pontchaillou
  • Service d'Urologie - Hôpital Bretonneau

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Tamsulosin

Placebo

Outcomes

Primary Outcome Measures

Time to stone elimination in days (censored criterion)

Secondary Outcome Measures

Time to stone elimination in days in patients with spontaneous elimination (quantitative criterion)
Pain using Visual Analogue Scale
Spontaneous stone elimination rate
Spontaneous stone elimination rate, according to stone size (2-3 mm, 4-5 mm, 6-7 mm)
Rate of need for surgery
Time to surgery in days in patients with surgical elimination
Rate of pain recurrences
Time to the first recurrence in days
Rate of need for corticoids or morphine
Time to the first administration of corticoids or morphine in days
Rate of adverse events

Full Information

First Posted
September 8, 2005
Last Updated
December 3, 2012
Sponsor
Rennes University Hospital
Collaborators
Ministry of Health, France, Yamanouchi
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1. Study Identification

Unique Protocol Identification Number
NCT00151567
Brief Title
Evaluation of Tamsulosin in the Treatment of Ureteral Stones
Acronym
TAMSULOSINE
Official Title
Interest of a Treatment With the alpha1-blocker Tamsulosin in the Elimination of Pelvis Ureteral Stones
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Rennes University Hospital
Collaborators
Ministry of Health, France, Yamanouchi

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureterolithiasis, Ureteral Calculi
Keywords
Ureterolithiasis, Alpha1-blocker, Lower ureteral stone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Tamsulosin
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Intervention Description
Oral tamsulosin once a day until stone elimination or the end of the follow-up (42 days)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral placebo of tamsulosin once a day until stone elimination or the end of the follow-up (42 days)
Primary Outcome Measure Information:
Title
Time to stone elimination in days (censored criterion)
Time Frame
between day 1 and 42
Secondary Outcome Measure Information:
Title
Time to stone elimination in days in patients with spontaneous elimination (quantitative criterion)
Time Frame
between day 1 and 42
Title
Pain using Visual Analogue Scale
Time Frame
days 1, 2, 3
Title
Spontaneous stone elimination rate
Time Frame
days 1, 7, 14, 21, 28, 35, and 42
Title
Spontaneous stone elimination rate, according to stone size (2-3 mm, 4-5 mm, 6-7 mm)
Time Frame
days 1, 7, 14, 21, 28, 35, and 42
Title
Rate of need for surgery
Time Frame
Within 42 days
Title
Time to surgery in days in patients with surgical elimination
Time Frame
between day 1 and day 42
Title
Rate of pain recurrences
Time Frame
within 42 days
Title
Time to the first recurrence in days
Time Frame
between day 1 and day 42
Title
Rate of need for corticoids or morphine
Time Frame
Within 42 days
Title
Time to the first administration of corticoids or morphine in days
Time Frame
between day 1 and day 42
Title
Rate of adverse events
Time Frame
Within 42 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francois Guillé, MD
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Bellissant, MD, PhD
Organizational Affiliation
Rennes University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Service d'Urologie- Hôpital du Val de Grâce
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Service d'Urologie - Hôpital de La Milétrie
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Hôpital de Redon
City
Redon
ZIP/Postal Code
35600
Country
France
Facility Name
Service d'Urologie- Hôpital Robert Debré
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Service d'Urologie- Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Service d'Urologie - Hôpital Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
16045553
Citation
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. doi: 10.1111/j.1442-2042.2005.01116.x.
Results Reference
background
PubMed Identifier
8957159
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. doi: 10.2165/00003495-199652060-00012.
Results Reference
background
PubMed Identifier
21149761
Citation
Vincendeau S, Bellissant E, Houlgatte A, Dore B, Bruyere F, Renault A, Mouchel C, Bensalah K, Guille F; Tamsulosin Study Group. Tamsulosin hydrochloride vs placebo for management of distal ureteral stones: a multicentric, randomized, double-blind trial. Arch Intern Med. 2010 Dec 13;170(22):2021-7. doi: 10.1001/archinternmed.2010.447.
Results Reference
derived

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Evaluation of Tamsulosin in the Treatment of Ureteral Stones

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