Safety of intravesical bladder instillations among patients with severe interstitial cystitis

• Conditions: Interstitial cystitis and bladder pain syndrome; MedDRA version: 18.1Level: LLTClassification code 10071166Term: Bladder pain syndromeSystem Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 18.1Level: PTClassification code 10011796Term: Cystitis interstitialSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2015-004495-30-FI
• Lead Sponsor: Oulu University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-20
• Last Update Posted: 28 December 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Age min 20 years
IC/PBS according to SUFU-criteria minium duration of 6 months
No suspicion of bladder cancer based on urine cytology and cystoscopy (performed within one year)
AUA treatment algorhitm level 3 treatments given without sufficient response
Signed informed consent
Fertile women commitment to reliable pregnancy preventive method during the trial. Male commitment to abstinence of use of condom during intercourse for 2 days after bladder instillation
Suitable for cystectomy to treat IC/PBS
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 4
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

Acute bacterial cystitis
Severe hypertension (over 160/100 mmHg)
Malignant disease within 5 years, excluding basal cell carcinoma
Radiation to pelvis
Residual urine over 150 ml
Significant renal detoriation
Allergy to cyclosporine
Pregnancy
Subject not suitable for trial based on investigator evaluation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified