Poitiers University Hospital - 2 rue de la Milétrie
Poitiers, 86021, France
Completed
NCT Number: NCT01061073
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.
Completed
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Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients aged 18 or more.
- Non-oncological indication to ureteral stenting
- 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
Treatment and study plan
Omexel
Drugspasfon
DrugPrimary outcomes
-
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
Secondary outcomes
-
incidence of complications
Time frame: after 1 month treatment
Sponsors and collaborators
Lead sponsor
Poitiers University Hospital
Other
Registry information
Important dates
- Study start
- 2010
- Primary completion
- 2012
- First posted
- Feb 2, 2010
- Registry last updated
- Oct 11, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.