NCT01061073
Completed
Phase 3
Evaluation of the Efficacy of Tamsulosin (Alpha Blockers) Compared to Phloroglucinol in Improving JJ Ureteral Stent Tolerance. A Randomized Controlled Trial
Poitiers University Hospital1 site in 1 country73 target enrollmentStarted: January 2010Last updated:
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Poitiers University Hospital
- Enrollment
- 73
- Locations
- 1
- Primary Endpoint
- Evaluate the benefit of alpha-blockers (Tamsulosin, group A) compared to phloroglucinol (Spasfon®, group B) as regards patients tolerance to JJ stents
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
- •Patients already treated with alpha blockers
Arms & Interventions
Omexel
Experimental
Intervention: Omexel (Drug)
spasfon
Active Comparator
Intervention: spasfon (Drug)
Outcomes
Primary 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(after 1 month treatment)
Investigators
Study Sites (1)
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