Skip to main content
OpenTrials
Completed

NCT Number: NCT00151567

Evaluation of Tamsulosin in the Treatment of 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ureterolithiasis Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Ureteral Calculi Ureteral Diseases Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Service d'Urologie- Hôpital du Val de Grâce, Paris, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tamsulosin

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Time to stone elimination in days (censored criterion)

    Time frame: between day 1 and 42

Secondary outcomes

  1. Time to stone elimination in days in patients with spontaneous elimination (quantitative criterion)

    Time frame: between day 1 and 42

  2. Pain using Visual Analogue Scale

    Time frame: days 1, 2, 3

  3. Spontaneous stone elimination rate

    Time frame: days 1, 7, 14, 21, 28, 35, and 42

  4. 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

  5. Rate of need for surgery

    Time frame: Within 42 days

  6. Time to surgery in days in patients with surgical elimination

    Time frame: between day 1 and day 42

  7. Rate of pain recurrences

    Time frame: within 42 days

  8. Time to the first recurrence in days

    Time frame: between day 1 and day 42

  9. Rate of need for corticoids or morphine

    Time frame: Within 42 days

  10. Time to the first administration of corticoids or morphine in days

    Time frame: between day 1 and day 42

  11. Rate of adverse events

    Time frame: Within 42 days

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Collaborators

  • Ministry of Health, France
  • Yamanouchi

Registry information

Official study title

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

Acronym: TAMSULOSINE

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
Sep 9, 2005
Registry last updated
Dec 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.