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

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)

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73 participants in 2 patient groups

Omexel

Experimental group

Treatment:

Drug: Omexel

spasfon

Active Comparator group

Treatment:

Drug: spasfon