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

December 3, 2012 updated by: Rennes University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

129

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75005
        • Service d'Urologie- Hôpital du Val de Grâce
      • Poitiers, France, 86021
        • Service d'Urologie - Hôpital de La Milétrie
      • Redon, France, 35600
        • Hôpital de Redon
      • Reims, France, 51092
        • Service d'Urologie- Hôpital Robert Debré
      • Rennes, France, 35033
        • Service d'Urologie- Hôpital Pontchaillou
      • Tours, France, 37044
        • Service d'Urologie - Hôpital Bretonneau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
EXPERIMENTAL: 1
Tamsulosin
Drug: Tamsulosin
Oral tamsulosin once a day until stone elimination or the end of the follow-up (42 days)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to stone elimination in days (censored criterion)
Time Frame: between day 1 and 42
between day 1 and 42

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Collaborators

Ministry of Health, France
Yamanouchi

Investigators

  • Principal Investigator: Francois Guillé, MD, Rennes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Primary Completion (ACTUAL)

December 1, 2006

Study Completion (ACTUAL)

December 1, 2006

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (ESTIMATE)

September 9, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

December 4, 2012

Last Update Submitted That Met QC Criteria

December 3, 2012

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFSSAPS 010751
  • PHRC/00-01 (OTHER: Rennes University Hospital)
  • CIC0203/004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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