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Evaluation of the Efficacy of Tamsulosin (Alpha Blockers) Compared to Phloroglucinol in Improving JJ Ureteral Stent Tolerance. A Randomized Controlled Trial

P

Poitiers University Hospital

Status and phase

Completed
Phase 3

Conditions

Non-oncological Indication to Ureteral Stenting

Treatments

Drug: Omexel
Drug: spasfon

Study type

Interventional

Funder types

Other

Identifiers

NCT01061073
JJ Alpha 2009

Details and patient eligibility

About

JJ ureteral stent represents an advance in the management of the upper urinary tract obstruction as it allows the patient to resume his activities although he is stented between the kidney and the bladder.

However, in many cases, this JJ stent is not well tolerated and can even be unbearable.

This trial evaluates the benefit of tamsulosin (an alpha-blocker) in improving the tolerance of JJ stents compared to low-doses of phloroglucinol.

Enrollment

73 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Patients aged 18 or more.
  2. Non-oncological indication to ureteral stenting
  3. Informed written consent

Exclusion criteria

1 Any contra-indication to Tamsulosin or phloroglucinol (renal or hepatic insufficiency, allergy) 2. Pregnancy 3. Patients already treated with alpha blockers

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

73 participants in 2 patient groups

Omexel
Experimental group
Treatment:
Drug: Omexel
spasfon
Active Comparator group
Treatment:
Drug: spasfon

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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