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

This study has been completed.
Sponsor:
Collaborators:
Ministry of Health, France
Yamanouchi
Information provided by:
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00151567
First received: September 8, 2005
Last updated: December 3, 2012
Last verified: September 2008
  Purpose

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 Intervention Phase
Ureterolithiasis
Ureteral Calculi
Drug: Tamsulosin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Interest of a Treatment With the alpha1-blocker Tamsulosin in the Elimination of Pelvis Ureteral Stones

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Time to stone elimination in days (censored criterion) [ Time Frame: between day 1 and 42 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to stone elimination in days in patients with spontaneous elimination (quantitative criterion) [ Time Frame: between day 1 and 42 ] [ Designated as safety issue: No ]
  • Pain using Visual Analogue Scale [ Time Frame: days 1, 2, 3 ] [ Designated as safety issue: No ]
  • Spontaneous stone elimination rate [ Time Frame: days 1, 7, 14, 21, 28, 35, and 42 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Rate of need for surgery [ Time Frame: Within 42 days ] [ Designated as safety issue: No ]
  • Time to surgery in days in patients with surgical elimination [ Time Frame: between day 1 and day 42 ] [ Designated as safety issue: No ]
  • Rate of pain recurrences [ Time Frame: within 42 days ] [ Designated as safety issue: No ]
  • Time to the first recurrence in days [ Time Frame: between day 1 and day 42 ] [ Designated as safety issue: No ]
  • Rate of need for corticoids or morphine [ Time Frame: Within 42 days ] [ Designated as safety issue: No ]
  • Time to the first administration of corticoids or morphine in days [ Time Frame: between day 1 and day 42 ] [ Designated as safety issue: No ]
  • Rate of adverse events [ Time Frame: Within 42 days ] [ Designated as safety issue: Yes ]

Enrollment: 129
Study Start Date: February 2002
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151567

Locations
France
Service d'Urologie- Hôpital du Val de Grâce
Paris, France, 75005
Service d'Urologie - Hôpital de La Milétrie
Poitiers, France, 86021
Hôpital de Redon
Redon, France, 35600
Service d'Urologie- Hôpital Robert Debré
Reims, France, 51092
Service d'Urologie- Hôpital Pontchaillou
Rennes, France, 35033
Service d'Urologie - Hôpital Bretonneau
Tours, France, 37044
Sponsors and Collaborators
Rennes University Hospital
Ministry of Health, France
Yamanouchi
Investigators
Principal Investigator: Francois Guillé, MD Rennes University Hospital
Study Chair: Eric Bellissant, MD, PhD Rennes University Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Direction of Clinical Research, Rennes University Hospital
ClinicalTrials.gov Identifier: NCT00151567     History of Changes
Other Study ID Numbers: AFSSAPS 010751, PHRC/00-01, CIC0203/004
Study First Received: September 8, 2005
Last Updated: December 3, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Rennes University Hospital:
Ureterolithiasis
Alpha1-blocker
Lower ureteral stone

Additional relevant MeSH terms:
Calculi
Ureteral Calculi
Ureterolithiasis
Pathological Conditions, Anatomical
Ureteral Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Tamsulosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014