NCT00151567

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2002

Longer than P75 for phase_3

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

December 4, 2012

Status Verified

September 1, 2008

Enrollment Period

4.8 years

First QC Date

September 8, 2005

Last Update Submit

December 3, 2012

Conditions

UreterolithiasisUreteral Calculi

Keywords

UreterolithiasisAlpha1-blockerLower ureteral stone

Outcome Measures

Primary Outcomes (1)

  • Time to stone elimination in days (censored criterion)

    between day 1 and 42

Secondary Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Tamsulosin

Drug: Tamsulosin

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

TamsulosinDRUG

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

1
PlaceboDRUG

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

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult over 18 years
  • Emergency admission for a ureteral colic
  • Radio-opaque ureterolithiasis
  • Stone of 2 to 7 mm diameter
  • Informed written consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Service d'Urologie- Hôpital du Val de Grâce

Paris, 75005, France

Location

Service d'Urologie - Hôpital de La Milétrie

Poitiers, 86021, France

Location

Hôpital de Redon

Redon, 35600, France

Location

Service d'Urologie- Hôpital Robert Debré

Reims, 51092, France

Location

Service d'Urologie- Hôpital Pontchaillou

Rennes, 35033, France

Location

Service d'Urologie - Hôpital Bretonneau

Tours, 37044, France

Location

Related Publications (3)

  • 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.

    PMID: 16045553BACKGROUND

  • 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.

    PMID: 8957159BACKGROUND

  • 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.

    PMID: 21149761DERIVED

MeSH Terms

Conditions

UreterolithiasisUreteral Calculi

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Ureteral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital DiseasesUrinary CalculiCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Study Officials

  • Francois Guillé, MD

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

  • Eric Bellissant, MD, PhD

    Rennes University Hospital

    STUDY CHAIR

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

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 9, 2005

Study Start

February 1, 2002

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

December 4, 2012

Record last verified: 2008-09

Locations

FR(6)