Evaluation of the Efficacy of Tamsulosin (Alpha Blockers) Compared to Phloroglucinol in Improving JJ Ureteral Stent Tolerance. A Randomized Controlled Trial
Phase 3
Completed
- Conditions
- Non-oncological Indication to Ureteral Stenting
- Interventions
- Drug: Omexel
- Registration Number
- NCT01061073
- Lead Sponsor
- Poitiers University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Omexel Omexel - spasfon spasfon -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method incidence of complications after 1 month treatment
Trial Locations
- Locations (1)
Poitiers University Hospital - 2 rue de la Milétrie
🇫🇷Poitiers, France