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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-oncological Indication to Ureteral Stenting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Omexel

Group Type EXPERIMENTAL

Omexel

Intervention Type DRUG

spasfon

Group Type ACTIVE_COMPARATOR

spasfon

Intervention Type DRUG

Interventions

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Omexel

Intervention Type DRUG

spasfon

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No