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

R

Rennes University Hospital

Status and phase

Completed
Phase 3

Conditions

Ureteral Calculi
Ureterolithiasis

Treatments

Drug: Tamsulosin
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00151567
PHRC/00-01 (Other Identifier)
AFSSAPS 010751
CIC0203/004

Details and patient eligibility

About

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.

Full 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.

Enrollment

129 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

129 participants in 2 patient groups, including a placebo group

1
Experimental group
Description:
Tamsulosin
Treatment:
Drug: Tamsulosin
2
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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