A Phase 4 interventional study of IALURIL Prefill in Bladder Pain Syndrome, sponsored by Radboud University Medical Center. Recruiting at 8 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-17.
Sponsored by Radboud University Medical Center · Phase 4, Interventional, and Treatment
Rationale:
Efficacy study (RCT) for glycosaminoglycan(GAG)-therapy for the indication bladder pain syndrome / interstitial cystitis with Hunner lesion subtype (BPS-IC H+). reason for this study is a current lack of evidence regarding its efficacy and cost-effectiveness.
Main objective is to determine short and long term efficacy of GAG therapy (bladder instillations) for people with BPS-IC H+ as compared to placebo treatment on dominant symptoms such as pain and Quality of Life (QOL)
Rationale:
Reimbursement in the Netherlands for GAG-therapy for bladder pain syndrome / interstitial cystitis patients with Hunner lesion subtype (BPS-IC H+) is under debate, as evidence regarding its efficacy and cost-effectiveness is lacking.
Objective:
Main objective is to determine short and long term efficacy of GAG therapy (bladder instillations) for people with BPS-IC H+ as compared to placebo treatment on dominant symptoms such as pain. Secondary objectives are to determine the 1) cost-effectiveness of GAG therapy, 2) effectiveness of GAG therapy on quality of life and bladder inflammation evaluated by urethrocystoscopy
Study design:
Multi-design study. Study is powered and set-up as double-blinded randomized intervention study and is extended with a double-blinded aggregated N-of-1 trial. As requested by the Zorginstituut Netherlands, the study will be further extended with a prospective, non-blinded intervention study to evaluate long term follow up with a low frequency therapy dose.
Study population:
People with symptomatic BPS-IC H+ (> 18 yrs old). A total of 80 patients will be included for the main study.
Intervention :
GAG bladder instillations (hyaluronic acid + chondroitin sulfate; Ialuril) 50ml administered with a catheter. Placebo will be Hypromellose 50ml administered with a catheter. Patients will receive instillations (Ialuril / placebo with ratio 2:1) in 3 periods of 6 wks with frequency of 1 instillation/wk. 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).
Main study parameters/endpoints:
Primary outcome parameter: change from baseline in maximum bladder pain (visual analogue scale (VAS) pain score (3d average and maximal pain score).
Secondary outcome parameters:
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Benefits patients and group relatedness. All participants are capacitated adults and will receive a similar amount of intervention and placebo treatments. Treatment corresponds to the Dutch NVU guideline BPS. Therapy will be reimbursed for patients. During 54wks, patients will have a 6 week period where placebo is given. Due to the study design, patients can obtain a personal (individual) study efficacy result if therapy was successful in him/her.
Therapy and placebo: risks and burden This study will be submitted as low-intervention trial. GAG therapy (instillations) has been used for >25 yrs in clinical practice to treat BPS-IC. GAG-therapies are registered as medical devices. The therapy is instilled into the bladder using a catheter (by nurse / patient). Catherization has a small increased risk for developing an urine tract infection (1.9%) [Herr 2015], urethral discomfort and in rare cases urethral trauma.
The placebo compound Hypromellose 0.3% is used as moisturizing drops to treat dry eyes. It is inert (non-irritating and hypo-allergenic). Very rare (\< 0.01%) side effects are reported in the Dutch 'Farmacologisch Kompas'. They report local side effects of sensitivity (burning, itch, tears e.d.). Blurry vision. and very rare systemic effects as rash, itch.Because of these reported side effects at inclusion the (over)sensitivity is checked by one drop in an eye, taking into account the possible blurry vision afterwards.
236 studies on the registry are indexed under Cystitis, Interstitial; 35 are open to participants now.
This study's planned enrollment of 80 is above the median of 51 across 158 interventional studies indexed under Cystitis, Interstitial.
Browse Cystitis, Interstitial studies →Radboud University Medical Center is the lead sponsor of 986 studies on the registry; 136 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment period 1: placebo for 1x/week for 6 weeks, followed by two treatment periods of 6 weeks receiving GAG-therapy (Ialuril) 1x/week. Finally this arm continues with unblinded GAG-therapy (Ialuril) instillations 1x/month for 6 instillations.
Device: IALURIL Prefill
Treatment period 1: GAG-therapy (Ialuril) for 1x/week for 6 weeks, followed by treatment period 2: Placebo for 1x/week for 6 weeks and afterwards treatment period 3: GAG-therapy (Ialuril) for 1/x week for 6 weeks. Finally, this arm continues with unblinded GAG-therapy (Ialuril) instillations 1x/month for 6 instillations.
Device: IALURIL Prefill
Treatment period 1: GAG-therapy (Ialuril) for 1x/week for 6 weeks, followed by treatment period 2: GAG-therapy (Ialuril) for 1x/week for 6 weeks and afterwards treatment period 3: placebo for 1/x week for 6 weeks. Finally, this arm continues with unblinded GAG-therapy (Ialuril) instillations 1x/month for 6 instillations.
Device: IALURIL Prefill
GAG therapy (bladder instillations with glycosaminoglycans)
Change in maximum bladder pain
VAS pain score (0-10; 0= no pain, 10=worst pain)
Time frame: Fase 1: Week 1,2,5,7,8,12,15,17,18,22,25,27,28,29 Fase 2:week 32, 36, 40, 44, 48, 54
Change in average bladder pain
VAS pain score (0-10; 0= no pain, 10=worst pain)
Time frame: Fase 1: Week 1,2,5,7,8,12,15,17,18,22,25,27,28,29 Fase 2:week 32, 36, 40, 44, 48, 54
7-point Global Response Assessment (GRA) scale
The GRA is a 7-point descriptive scale, scores of 1-3 indicate worsening of symptoms, and 5-7 indicate and improvement in symptoms
Time frame: Fase 1: Week 1,2,5,7,8,12,15,17,18,22,25,27,28,29 Fase 2:week 32, 36, 40, 44, 48, 54
Change in patient assessed most dominant symptom
VAS score (0-10; 0= no burden, 10=high burden)
Time frame: Fase 1: Week 1,2,5,7,8,12,15,17,18,22,25,27,28,29 Fase 2:week 32, 36, 40, 44, 48, 54
Voiding urgency
as single item from the validated Genito-Urinary Pain Index questionnaire (5 point Likert scale)
Time frame: Fase 1: Week 1,2,5,7,8,12,15,17,18,22,25,27,28,29 Fase 2:week 32, 36, 40, 44, 48, 54
Voiding frequency
as single item from the validated Genito-Urinary Pain Index questionnaire (5 point Likert scale)
Time frame: Fase 1: Week 1,2,5,7,8,12,15,17,18,22,25,27,28,29 Fase 2:week 32, 36, 40, 44, 48, 54
O'leary Sant interstitial cystitis symptom index/problem index (ICSI/ICPI)
Validated BPS-IC related symptom questionaire
Time frame: week 1, 6, 18, 28, 29, 40, 48
Patient Reported Outcome Measurement (PROM) short and extended
Improvement (0-100%), continue treatment, reccommend to family, including Adverse Events and start/stop other treatment for BPS/IC
Time frame: week 1, 8, 18, 28, 29, 40, 48
Voiding diary
2x24h
Time frame: at baseline
Quality of Life questionnaire
Outcome of ED-5D 5L QoL questionnaire
Time frame: week 1, 6, 18, 28, 29, 40, 48
Urine sediment
Screening for bacterial urinary tract infection
Time frame: week 1, 6, 18, 28, 29, 40, 48
Cost effectiveness
iMCQ and iPCQ questionaires
Time frame: week 1, 8, 18, 28
Cystoscopic evaluation
Likert scale inflammation (1-5)
Time frame: week 8 and week 28
Plan to share: No — only anonymous patient data will be shared
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