Interstitial Cystitis MedDRA version: 9.1 Level: HLGT Classification code 10018188
Conditions
Interventions
Trade Name: RIMSO 50
Pharmaceutical Form: Bladder irrigation
INN or Proposed INN: Dimethyl sulfoxide
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: .54-
Sponsors
IBSA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female patients aged greater than or equal to 18 years 2. Diagnosis of IC / BPS resistant to first-line treatment of non-invasive or early observation 3. Presence of pain (pelvic pressure or discomfort) in relation to the bladder accompanied by at least one other urinary symptom such as persistent urge to urinate or frequent urination at least six months 4. Discomfort or pain during intercourse 5. Women of childbearing potential must have negative pregnancy test 6. Subjects in the four previous months have not participated in other trials. 7. Written informed 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: . Patients younger than 18 years 2. Male patients 3. Patients who are pregnant and / or lactation 4. Confusable Diseases as the main cause of urinary symptoms ( 5. Previous intravesical treatment for IC / BPS. .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluating the effectiveness of Ialuril in patients with IC / BPS resistant to first-line treatment of non-invasive;Secondary Objective: Secondary objectives are: - Additional assessments related to pain / performance voiding - Evaluation of the tolerability of treatment administered - Measuring quality of life associated with health - Economic considerations on the cost of treatment versus intravesical DMSO Ialuril and pathology IC / BPS before treatment.;Primary end point(s): The primary endpoint will be represented by the visual-analogue scale (VAS) for pain assessment, graduation 0-100, administered at baseline and after 3 and 6 months | — |
Countries
Italy
Outcome results
None listed