Evaluation of the Efficacy of Tamsulosin (Alpha Blockers) Compared to Phloroglucinol in Improving JJ Ureteral Stent Tolerance. A Randomized Controlled Trial
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||Drug: Omexel Drug: spasfon||Phase 3|
|Study Design:||Allocation: Randomized
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 ]
- incidence of complications [ Time Frame: after 1 month treatment ]
|Study Start Date:||January 2010|
|Primary Completion Date:||October 2012 (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
|Poitiers University Hospital - 2 rue de la Milétrie|
|Poitiers, France, 86021|