Confirmed or potential ureteral obstruction with a uretral stenting indication. MedDRA version: 12.0 Level: LLT Classification code 10050307 Term: Ureteral stent insertion
Conditions
Interventions
Trade Name: OMEXEL
Pharmaceutical Form: Tablet
Trade Name: SPASFON
Pharmaceutical Form: Tablet
Sponsors
CHU DE POITIERS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 or more. 2. Non-oncological indication to ureteral stenting 3. Informed written consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any contra-indication to Tamsulosin or phloroglucinol (renal or hepatic insufficiency, allergy) 2. Pregnancy 3. Patients already treated with alpha blockers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the benefit of alpha-blockers (Tamsulosin, group A) compared to phloroglucinol (Spasfon®, group B) as regards patients tolerance to JJ stents.;Secondary Objective: To compare the incidence of complications between the 2 groups;Primary end point(s): Ureteral Stent Symptom Questionnaire (USSQ) self-questionnaire score comparaison | — |
Countries
France
Outcome results
None listed