Thomas Lois H, Watkins Caroline L, Sutton Christopher J, Forshaw Denise, Leathley Michael J, French Beverley, Burton Christopher R, Cheater Francine, Roe Brenda, Britt David, Booth Joanne, McColl Elaine
School of Health, University of Central Lancashire, Victoria Street, Preston PR1 2HE, UK.
Trials. 2014 Dec 23;15:509. doi: 10.1186/1745-6215-15-509.
Urinary incontinence (UI) affects half of patients hospitalised after stroke and is often poorly managed. Cochrane systematic reviews have shown some positive impact of conservative interventions (such as bladder training) in reducing UI, but their effectiveness has not been demonstrated with stroke patients.
We conducted a cluster randomised controlled feasibility trial of a systematic voiding programme (SVP) for the management of UI after stroke. Stroke services were randomised to receive SVP (n = 4), SVP plus supported implementation (SVP+, n = 4), or usual care (UC, n = 4).Feasibility outcomes were participant recruitment and retention. The main effectiveness outcome was presence or absence of UI at six and 12 weeks post-stroke. Additional effectiveness outcomes included were the effect of the intervention on different types of UI, continence status at discharge, UI severity, functional ability, quality of life, and death.
It was possible to recruit patients (413; 164 SVP, 125 SVP+, and 124 UC) and participant retention was acceptable (85% and 88% at six and 12 weeks, respectively). There was no suggestion of a beneficial effect on the main outcome at six (SVP versus UC: odds ratio (OR) 0.94, 95% CI: 0.46 to 1.94; SVP+ versus UC: OR: 0.62, 95% CI: 0.28 to 1.37) or 12 weeks (SVP versus UC: OR: 1.02, 95% CI: 0.54 to 1.93; SVP+ versus UC: OR: 1.06, 95% CI: 0.54 to 2.09).No secondary outcomes showed a strong suggestion of clinically meaningful improvement in SVP and/or SVP+ arms relative to UC at six or 12 weeks. However, at 12 weeks both intervention arms had higher estimated odds of continence than UC for patients with urge incontinence.
The trial has met feasibility outcomes of participant recruitment and retention. It was not powered to demonstrate effectiveness, but there is some evidence of a potential reduction in the odds of specific types of incontinence. A full trial should now be considered.
ISRCTN Registry, ISRCTN08609907, date of registration: 7 July 2010.
尿失禁（UI）影响着半数中风后住院的患者，且管理往往不善。Cochrane系统评价显示保守干预措施（如膀胱训练）在减少尿失禁方面有一定积极影响，但在中风患者中其有效性尚未得到证实。
我们开展了一项整群随机对照可行性试验，以评估系统性排尿计划（SVP）对中风后尿失禁的管理效果。中风服务机构被随机分为接受SVP（n = 4）、SVP加支持实施（SVP +，n = 4）或常规护理（UC，n = 4）。可行性结果指标为参与者的招募和留存情况。主要有效性结果指标为中风后6周和12周时是否存在尿失禁。其他有效性结果指标包括干预对不同类型尿失禁的影响、出院时的控尿状态、尿失禁严重程度、功能能力、生活质量及死亡情况。
有可能招募到患者（413例；164例接受SVP，125例接受SVP +，124例接受UC），且参与者留存情况尚可（6周和12周时分别为85%和88%）。在6周（SVP与UC相比：优势比（OR）0.94，95%置信区间：0.46至1.94；SVP +与UC相比：OR：0.62，95%置信区间：0.28至1.37）或12周时（SVP与UC相比：OR：1.02，95%置信区间：0.54至1.93；SVP +与UC相比：OR：1.06，95%置信区间：0.54至2.09），未显示出对主要结果有有益影响。在6周或12周时，相对于UC，没有次要结果强烈表明SVP和/或SVP +组有临床意义的改善。然而，在12周时，对于急迫性尿失禁患者，两个干预组的控尿估计优势比均高于UC组。
该试验达到了参与者招募和留存的可行性结果。其样本量不足以证明有效性，但有一些证据表明特定类型尿失禁的发生几率可能降低。现在应考虑进行全面试验。
ISRCTN注册库，ISRCTN08609907，注册日期：2010年7月7日。
