GAG-therapy Efficacy Trial Solution for Bladder Pain Syndrome/ Interstitial Cystitis
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 80
- Locations
- 8
- Primary Endpoint
- Change in maximum bladder pain
Study Overview
Brief Summary
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)
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Masking Description
double blinded by care provider (person giving the treatment) and the participant (blinded syringes en placebo product)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients (18 yrs or older) with symptomatic BPS with established Hunner lesions objectified with urethrocystoscopy in the 3 months prior to inclusion.
- •A VAS pain score (maximum pain during the last 3 days; scale 0-10) of at least 4.
Exclusion Criteria
- •pain, discomfort in pelvic region of inflammatory bladder conditions due to any cause other than BPS with Hunner lesions, with the exception of irritable bowel syndrome (IBS) and hypertonic pelvic floor or urine tract infections (UTI; <3 UTI's / year). This is noted by ESSIC as a confusable disease [van de Merwe 2007, contains an elaborate table for this].
- •had a urine tract infection in the previous 6 weeks.
- •received bladder instillations for BPS in the previous 3 months;
- •received intradetrusor Botulinum toxin (BOTOX) injections within the previous 12 months.
- •received transurethral coagulation/ablation therapy of Hunner lesions within the last 12 months, with the exception of patients who have objectified Hunner lesion recurrence(s) on cystoscopy after coagulation/ablation therapy after at least 3 months' post-intervention.
- •started a new treatment for (chronic) pain (pharmacotherapy) or urine tract infection in the last month.
- •Unable (also legal) to give informed consent.
- •Allergic to Hypromellose (tested in one eye)
Arms & Interventions
Placebo - Intervention - Intervention
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.
Intervention: IALURIL Prefill (Device)
Intervention - Placebo - Intervention
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.
Intervention: IALURIL Prefill (Device)
Intervention - Intervention - Placebo
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.
Intervention: IALURIL Prefill (Device)
Outcomes
Primary Outcomes
Change in maximum bladder 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
VAS pain score (0-10; 0= no pain, 10=worst pain)
Secondary Outcomes
- Voiding diary(at baseline)
- Cystoscopic evaluation(week 8 and week 28)
- Voiding urgency(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(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)(week 1, 6, 18, 28, 29, 40, 48)
- 7-point Global Response Assessment (GRA) scale(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(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)
- Quality of Life questionnaire(week 1, 6, 18, 28, 29, 40, 48)
- Cost effectiveness(week 1, 8, 18, 28)
- Patient Reported Outcome Measurement (PROM) short and extended(week 1, 8, 18, 28, 29, 40, 48)
- Urine sediment(week 1, 6, 18, 28, 29, 40, 48)
- Change in average bladder pain(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)