Evaluation of the Efficacy of Tamsulosin (Alpha Blockers) Compared to Phloroglucinol in Improving JJ Ureteral Stent Tolerance. A Randomized Controlled Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01061073|
Recruitment Status : Completed
First Posted : February 2, 2010
Last Update Posted : October 11, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Non-oncological Indication to Ureteral Stenting||Drug: Omexel Drug: spasfon||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||73 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Efficacy of Tamsulosin (Alpha Blockers) Compared to Phloroglucinol in Improving JJ Ureteral Stent Tolerance. A Randomized Controlled Trial|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||October 2012|
|Experimental: Omexel||Drug: Omexel|
|Active Comparator: spasfon||Drug: spasfon|
- Evaluate the benefit of alpha-blockers (Tamsulosin, group A) compared to phloroglucinol (Spasfon®, group B) as regards patients tolerance to JJ stents [ Time Frame: 1 month treatment ]
- incidence of complications [ Time Frame: after 1 month treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01061073
|Poitiers University Hospital - 2 rue de la Milétrie|
|Poitiers, France, 86021|