Safety of intravesical bladder instillations among patients with severe interstitial cystitis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004495-30-FI

Enrollment

Registered

2015-10-20

Start date

2015-12-14

Completion date

Unknown

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial cystitis and bladder pain syndrome MedDRA version: 18.1 Level: LLT Classification code 10071166 Term: Bladder pain syndrome System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 18.1 Level: PT Classification code 10011796 Term: Cystitis interstitial System Organ Class: 10038359 - Renal and urinary disorders

Interventions

Trade Name: SANDIMMUN Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: CICLOSPORIN CAS Number: 59865-13-3

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Safety of intravesical cyclosporine among patients with severe interstitial cystitis/painful bladder syndrome.;Secondary Objective: The effect of dose to symptoms.;Primary end point(s): Greatest safe intravesical cyclosporine dose. Definition of safe dose: measured cyclosporine concentration in blood <50.;Timepoint(s) of evaluation of this end point: Before every dose and after 4 hours of every dose, and End of trial visit at 30 (28-32) days.	—

Measure

Time frame

Main Objective: Safety of intravesical cyclosporine among patients with severe interstitial cystitis/painful bladder syndrome.;Secondary Objective: The effect of dose to symptoms.;Primary end point(s): Greatest safe intravesical cyclosporine dose. Definition of safe dose: measured cyclosporine concentration in blood <50.;Timepoint(s) of evaluation of this end point: Before every dose and after 4 hours of every dose, and End of trial visit at 30 (28-32) days.

—

Secondary

Measure	Time frame
Secondary end point(s): The effect of dose to symptoms. Based on PORIS-questionnaire score.;Timepoint(s) of evaluation of this end point: Every visit from visit day 3 to End of trial visit at day 30 (28-32).	—

Countries

Finland

Contacts

Public ContactUrologian avohoitoyksikkö

Oulu University Hospital

markku.h.vaarala@ppshp.fi

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026