Bladderpain syndrome/ interstitial cystitis Bladder pain syndrome
Conditions
Interventions
GAG bladder instillations (hyaluronic acid + chondroitin sulfate
Ialuril) 50ml 
administered with a catheter. Placebo will be artificial Tears (three options: 
Hypromellose 0,3% (Artelac), Hypromellose 3mg/Dextran 70mg (Duratears) en 
Povidon 20mg (Protagens), with these products an 50mL placebo instillation will 
be made and administred per katheter. There are 3 periods of 6 wks with 
frequency of 1 instillation/wk (ratio intervention/placebo is 2:1). With 
wash-out periods 4 wks. After 3 periods of treatment / placebo (wk 30), 
blinding will cease and continue unblinded where all subjects will receive 
maintenance therapy Ialuril for 1x/4wk until 54 weeks (endpoint). 
If needed (e.g. vacation patient), the wash-out period can be extended and the 
start of the treatment period postponed for a maximum of 5 weeks, minimal 
wash-out period of 4 weeks. 
During the study we found out the production of articifial tears is very 
unstable and results in many delivery and storage problems. In the normal 
clinic the Pharmacist changes between artificial tears to prescribe (depending 
on availability). Because of this we have decided to have three placebo 
options, in case of storage Artelac is the first choice, followed by Duratears 
and final Protagens. In this way the study is less vunerable and continuity is 
maintained. On 29th of July 2022 we had to change the placebo acutely to 
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Adult patients (18 yrs or older) with symptomatic BPS with established Hunner lesions objectified with urethrocystoscopy in the 3 months prior to inclusion. 2) A VAS pain score (maximum pain during the last 3 days; scale 0-10) of at least 4.
Exclusion criteria
Exclusion criteria: 1) pain, discomfort in pelvic region of inflammatory bladder conditions due to any cause other than BPS with Hunner lesions, 2) a urine tract infection in the previous 6 weeks 3) received bladder instillations for BPS in the previous 3 months 4) received intradetrusor Botulinum toxin (BOTOX) injections within the previous 12 months 5) received transurethral coagulation/ablation therapy of Hunner lesions within the last 12 months 6) started a new treatment for (chronic) pain (pharmacotherapy) or urine tract infection in the last month. 7) Unable (also legal) to give informed consent. 8) Allergy/Sensibilisation for artificial tears (this will be tested by applying one drop in one eye).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome parameter: change from baseline in VAS pain score (3d average and maximal pain score). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome parameters: - Change from baseline in VAS score (0-10) on self-reported secondary symptoms - Change from baseline from self-reported Global Assessment of Improvement (Likert scale) - Change from baseline from O*Leary-Sant IC Symptom Index & Problem Index questionnaire - Change from baseline in urethrocystoscopical evaluation of bladder mucosa (inflammation, active Hunner lesions) (clinician assessed estimated % of inflammation & degree of inflammation) - Change from baseline in Quality of Life using ED-5D 5L questionnaire (Dutch) - Cost effectiveness analyses using iMCQ and iPCQ questionnaires - Changes in Patient Reported Outcome questionnaire (incl. urinary frequency) - Adverse events using Clavien-Dindo system | — |
Countries
Netherlands
Contacts
Public ContactDAW Janssen
Radboud Universitair Medisch Centrum
Outcome results
None listed