Lancashire Clinical Trials Unit, Applied Health Research Hub, University of Central Lancashire, Preston, UK.
Faculty of Health and Care, University of Central Lancashire, Preston, UK.
Health Technol Assess. 2022 Jul;26(31):1-88. doi: 10.3310/EFTV1270.
Urinary incontinence affects around half of stroke survivors in the acute phase, and it often presents as a new problem after stroke or, if pre-existing, worsens significantly, adding to the disability and helplessness caused by neurological deficits. New management programmes after stroke are needed to address urinary incontinence early and effectively.
The Identifying Continence OptioNs after Stroke (ICONS)-II trial aimed to evaluate the clinical effectiveness and cost-effectiveness of a systematic voiding programme for urinary incontinence after stroke in hospital.
This was a pragmatic, multicentre, individual-patient-randomised (1 : 1), parallel-group trial with an internal pilot.
Eighteen NHS stroke services with stroke units took part.
Participants were adult men and women with acute stroke and urinary incontinence, including those with cognitive impairment.
Participants were randomised to the intervention, a systematic voiding programme, or to usual care. The systematic voiding programme comprised assessment, behavioural interventions (bladder training or prompted voiding) and review. The assessment included evaluation of the need for and possible removal of an indwelling urinary catheter. The intervention began within 24 hours of recruitment and continued until discharge from the stroke unit.
The primary outcome measure was severity of urinary incontinence (measured using the International Consultation on Incontinence Questionnaire) at 3 months post randomisation. Secondary outcome measures were taken at 3 and 6 months after randomisation and on discharge from the stroke unit. They included severity of urinary incontinence (at discharge and at 6 months), urinary symptoms, number of urinary tract infections, number of days indwelling urinary catheter was in situ, functional independence, quality of life, falls, mortality rate and costs. The trial statistician remained blinded until clinical effectiveness analysis was complete.
The planned sample size was 1024 participants, with 512 allocated to each of the intervention and the usual-care groups. The internal pilot did not meet the target for recruitment and was extended to March 2020, with changes made to address low recruitment. The trial was paused in March 2020 because of COVID-19, and was later stopped, at which point 157 participants had been randomised (intervention, = 79; usual care, = 78). There were major issues with attrition, with 45% of the primary outcome data missing: 56% of the intervention group data and 35% of the usual-care group data. In terms of the primary outcome, patients allocated to the intervention group had a lower score for severity of urinary incontinence (higher scores indicate greater severity in urinary incontinence) than those allocated to the usual-care group, with means (standard deviations) of 8.1 (7.4) and 9.1 (7.8), respectively.
The trial was unable to recruit sufficient participants and had very high attrition, which resulted in seriously underpowered results.
The internal pilot did not meet its target for recruitment and, despite recruitment subsequently being more promising, it was concluded that the trial was not feasible owing to the combined problems of poor recruitment, poor retention and COVID-19. The intervention group had a slightly lower score for severity of urinary incontinence at 3 months post randomisation, but this result should be interpreted with caution.
Further studies to assess the effectiveness of an intervention starting in or continuing into the community are required.
This trial is registered as ISRCTN14005026.
This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 26, No. 31. See the NIHR Journals Library website for further project information.
大约有一半的急性脑卒中幸存者会出现尿失禁，而且这种情况常常是在脑卒中后出现新问题，或者如果之前就存在，那么情况会显著恶化，增加由神经功能缺损引起的残疾和无助感。需要新的管理方案来早期有效地治疗脑卒中后的尿失禁。
尿失禁识别选择方案-2 期临床试验（Identifying Continence OptioNs after Stroke-2，ICONS-2）旨在评估针对脑卒中后尿失禁的系统排尿方案的临床有效性和成本效益，该方案在医院内实施。
这是一项实用、多中心、个体患者随机（1∶1）、平行组试验，设有内部预试验。
18 家具有脑卒中单元的 NHS 脑卒中服务机构参与了这项研究。
参与者为患有急性脑卒中且伴有尿失禁的成年男女，包括伴有认知障碍的患者。
参与者被随机分配到干预组（接受系统排尿方案）或常规护理组。系统排尿方案包括评估、行为干预（膀胱训练或提示排尿）和复查。评估包括评估是否需要和可能去除留置导尿管。干预措施在招募后 24 小时内开始，并持续到脑卒中单元出院。
主要结局测量指标是随机分组后 3 个月时尿失禁的严重程度（使用国际尿失禁咨询问卷进行测量）。次要结局测量指标在随机分组后 3 个月和 6 个月以及脑卒中单元出院时进行测量，包括尿失禁严重程度（出院时和 6 个月时）、尿失禁症状、尿路感染次数、留置导尿管天数、功能独立性、生活质量、跌倒、死亡率和成本。试验统计人员在临床有效性分析完成之前保持盲态。
计划样本量为 1024 名参与者，每组 512 名，干预组和常规护理组各分配 512 名。内部预试验没有达到招募目标，并延长至 2020 年 3 月，在此期间进行了更改以解决低招募问题。由于 COVID-19，试验于 2020 年 3 月暂停，之后停止，此时已随机分配 157 名参与者（干预组，n=79；常规护理组，n=78）。失访率极高，导致主要结局数据缺失率为 45%：干预组数据缺失率为 56%，常规护理组数据缺失率为 35%。就主要结局而言，与常规护理组相比，接受干预组的患者尿失禁严重程度评分较低（分数越高表示尿失禁越严重），分别为 8.1（7.4）和 9.1（7.8）。
试验未能招募足够的参与者，失访率极高，导致结果的效力严重不足。
内部预试验未达到招募目标，尽管随后的招募情况更有希望，但由于招募困难、保留率低和 COVID-19 的综合问题，试验最终被认为不可行。随机分组后 3 个月时，干预组尿失禁严重程度评分略低，但应谨慎解释这一结果。
需要进一步研究以评估起始于或继续延续到社区的干预措施的有效性。
本试验在 ISRCTN 注册，注册号为 ISRCTN81120313。
本项目由英国国家卫生与保健优化研究所（NIHR）卫生技术评估计划资助，全文将在 ; 第 26 卷，第 31 期发表。欲了解更多项目信息，请访问 NIHR 期刊库网站。
