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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01061073

Enrollment

Registered

2010-02-02

Start date

2010-01-31

Completion date

Unknown

Last updated

2016-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-oncological Indication to Ureteral Stenting

Brief summary

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.

Interventions

DRUGOmexel

DRUGspasfon

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Evaluate the benefit of alpha-blockers (Tamsulosin, group A) compared to phloroglucinol (Spasfon®, group B) as regards patients tolerance to JJ stents	1 month treatment

Secondary

Measure	Time frame
incidence of complications	after 1 month treatment

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026