Evaluation of the Efficacy of Tamsulosin (Alpha Blockers) Compared to Phloroglucinol in Improving JJ Ureteral Stent Tolerance. A Randomized Controlled Trial
Recruitment status was Recruiting
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.
Non-oncological Indication to Ureteral Stenting
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the Efficacy of Tamsulosin (Alpha Blockers) Compared to Phloroglucinol in Improving JJ Ureteral Stent Tolerance. A Randomized Controlled Trial|
- 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 ] [ Designated as safety issue: No ]
- incidence of complications [ Time Frame: after 1 month treatment ] [ Designated as safety issue: No ]
|Study Start Date:||February 2010|
|Estimated Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
|Experimental: Omexel||Drug: Omexel|
|Active Comparator: spasfon||Drug: spasfon|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01061073
|Contact: Jacques IRANI, MDfirstname.lastname@example.org|
|Poitiers University Hospital - 2 rue de la Milétrie||Recruiting|
|Poitiers, France, 86021|
|Contact: Jacques IRANI, MD 05 49 44 44 75 email@example.com|