GAG-therapy Efficacy Trial Solution for Bladder Pain Syndrome/ Interstitial Cystitis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 16
- 主要终点
- Change in maximum bladder pain
研究概览
简要总结
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)
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
double blinded by care provider (person giving the treatment) and the participant (blinded syringes en placebo product)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
Change in maximum bladder pain
时间窗: 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)
次要结局
- 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)
- Voiding diary(at baseline)
- O'leary Sant interstitial cystitis symptom index/problem index (ICSI/ICPI)(week 1, 6, 18, 28, 29, 40, 48)
- 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)
- 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)
- Cystoscopic evaluation(week 8 and week 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)