Evaluation of product adsorption onto the bladder walls of healthy women and patients with damaged bladder epithelium Urological and Genital Diseases
Conditions
Interventions
Pilot 1 investigation:
On day 1 of two periods, 3 subjects will receive by intravesical instillation a single dose of 20 mL Methylene blue 0.1% using Ialuadapter® in the first period
Sponsors
IBSA Institut Biochimique (Switzerland)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Informed consent: signed written informed consent before inclusion in the investigation 2. Sex and Age: women, 18-55 years old inclusive 3. Body Mass Index (BMI): 18.5-30 kg/m2 inclusive 4. Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest in the sitting position 5. Full comprehension: ability to comprehend the full nature and purpose of the investigation, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire investigation 6. Contraception and fertility: women of child-bearing potential must be using at least one of the following reliable methods of contraception: 6.1. Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit 6.2. A non-hormonal intrauterine device [IUD] or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit 6.3. A male sexual partner who agrees to use a male condom with spermicide 6.4. A sterile sexual partner Women of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted. For all women, pregnancy test result must be negative at screening and day 1. Additional inclusion criteria for Pilot 2 part only: 7. Patients with damaged bladder epithelium due to chronic cystitis, interstitial cystitis or painful bladder syndrome
Exclusion criteria
Exclusion criteria: 1. Electrocardiogram (ECG 12-leads, supine position): clinically significant abnormalities 2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the investigation 3. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness 4. Urinary diseases: presence of any specific urinary symptoms detected through questioning at Screening during the physical examination visit, except for the patients enrolled in pilot 2 part (see inclusion criterion N. 7) 5. Bladder status: Bladder urine volume after spontaneous urination before treatment = 100 mL as detected by suprapubical ultrasound examination (day 1) 6. Infection history: history of bacterial urinary tract or bacterial or fungal vaginal infections for 3 weeks before the screening visit, except for the patients enrolled in pilot 2 part (see inclusion criterion N. 7) 7. Systemic infections: bacterial or fungal infections that may interfere with the aim of the investigation or affect the subject’s safety (positive urino-culture for E.coli, other gram negative bacteria, Staphylococcus spp, Streptococcus spp, Enterococcus spp, Corynebacterium spp or Yeasts), except for the patients enrolled in pilot 2 part (see inclusion criterion N. 7) 8. Urethral opening conditions: altered urethral opening conditions affecting the site of insertion (e.g. irritation or other). 9. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients of the investigational product, to Methylene Blue (AxP) or to any other thiazine dies; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the investigation 10. Diseases: moderate or severe renal disease or significant history of urinary tract, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine, psychiatric or neurological diseases that may interfere with the aim of the investigation and in particular asthma, anemia (Hb values 1.5. Hormonal contraceptives will be allowed. Treatments taken by the patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bladder walls stain distribution and intensity by cystoscopy imaging after Ialuril® administration followed (after 30 minutes) by Methylene blue administration using Ialuadapter® (Test treatment; T2) and through a catheter (Reference treatment; R2) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Treatment-Emergent Adverse Events (TEAEs) collected using specific data capture forms filled in by the Investigator during the study from screening up to Final Visit /ETV 2. Device Deficiencies (DDs) collected using specific data capture forms filled in by the Investigator during the study from screening up to Final Visit /ETV 3. Local tolerability at the administration site measured by collecting comments made by the subjects regarding discomfort or any other inconvenience during and after instillation 4. Physical abnormalities collected using specific data capture forms filled in by the Investigator during the study from screening up to Final Visit /ETV 5. Vital signs (blood pressure and heart rate) measured at screening, on day 1 and final visit/ETV 6. Body weight (kg) measured at screening and final visit/ETV 7. Safety laboratory analysis results measured at the screening visit and final visit/ETV | — |
Countries
Switzerland
Outcome results
None listed