Internet-based treatment of stress urinary incontinence: 1- and 2-year results of a randomized controlled trial with a focus on pelvic floor muscle training.

Internet-based treatment of stress urinary incontinence: 1- and 2-year results of a randomized controlled trial with a focus on pelvic floor muscle training.
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DOI:
10.1111/bju.13091
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发表时间:
2015-12
期刊:
影响因子:
4.5
通讯作者:
Samuelsson E
Samuelsson E
中科院分区:
医学2区
文献类型:
--
作者:
Sjöström M;Umefjord G;Stenlund H;Carlbring P;Andersson G;Samuelsson E

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评价两种基于盆底肌训练(PFMT)的非面对面治疗方案治疗压力性尿失禁(SUI)的长期效果。本研究是一项随机对照试验,在线招募了250名年龄在18-70岁之间的社区居住女性,SUI ≥ 1次/周。诊断是基于有效的自我评估问卷,2天膀胱日记和电话采访的泌尿治疗师。进行连续计算机生成的区组随机化,由独立管理员分配至3个月的治疗,治疗方案为基于互联网的治疗方案(n = 124)或邮寄方案(n = 126)。这两项干预措施主要侧重于PFMT。互联网组从泌尿治疗师那里获得持续的电子邮件支持,而邮政组则自己训练。随访1年和2年后,通过自我评估的邮政问卷。主要结局是症状严重程度(国际咨询调查问卷简表[ICIQ-UI SF])和特定条件生活质量(ICIQ-下尿路症状生活质量[ICIQ-LUTSqol])。次要结局是患者总体改善印象、健康特定生活质量(EQ-视觉模拟量表[EQ-VAS])、失禁辅助器具的使用和治疗满意度。在任何时候都没有与参与者进行面对面的接触。分析是基于意向治疗。我们失去了32.4%(81/250)的参与者随访后1年和38.0%(95/250)后2年。通过这两种干预措施,我们观察到1年和2年后症状和疾病特异性生活质量(QoL)的显著改善(P < 0.001)和较大的效应量(>0.8)。两组间无显著差异。1年后,互联网组和邮政组的症状评分平均(标准差)变化分别为3.7(3.3)和3.2(3.4)(P = 0.47),2年后互联网组和邮政组的症状评分平均(标准差)变化分别为3.6(3.5)和3.4(3.3)(P = 0.79)。1年后,互联网组和邮政组的条件特异性生活质量平均变化(sd)分别为5.5(6.5)和4.7(6.5)(P = 0.55),2年后互联网组和邮政组分别为6.4(6.0)和4.8(7.6)(P = 0.28)。一年后,两个干预组中认为自己有很大或很大改善的参与者比例相似(互联网,31.9% [28/88];邮政,33.8% [27/80],P = 0.82),但两年后,互联网组中有更多的参与者报告了这种程度的改善,(39.2% [29/74] vs 23.8% [19/80],P = 0.03)。2年后,互联网组的健康特定生活质量显著改善(EQ-VAS平均变化为3.8 [11.4],P = 0.005)。我们没有发现在这方面的其他重大改进。在治疗后1年,69.8%(60/86)的互联网组参与者和60.5%(46/76)的邮政组参与者报告他们仍然对治疗结果感到满意。2年后分别为64.9%(48/74)和58.2%(46/79)。在治疗后1年和2年,使用PFMT对SUI进行非面对面治疗可显著改善症状和疾病特异性QoL,且具有临床相关性。
To evaluate the long-term effects of two non-face-to-face treatment programmes for stress urinary incontinence (SUI) based on pelvic floor muscle training (PFMT). The present study was a randomized controlled trial with online recruitment of 250 community-dwelling women aged 18–70 years with SUI ≥ one time/week. Diagnosis was based on validated self-assessed questionnaires, 2-day bladder diary and telephone interview with a urotherapist. Consecutive computer-generated block randomization was carried out with allocation by an independent administrator to 3 months of treatment with either an internet-based treatment programme (n = 124) or a programme sent by post (n = 126). Both interventions focused mainly on PFMT. The internet group received continuous e-mail support from a urotherapist, whereas the postal group trained on their own. Follow-up was performed after 1 and 2 years via self-assessed postal questionnaires. The primary outcomes were symptom severity (International Consultation on Incontinence Questionnaire Short Form [ICIQ-UI SF]) and condition-specific quality of life (ICIQ-Lower Urinary Tract Symptoms Quality of Life [ICIQ-LUTSqol]). Secondary outcomes were the Patient Global Impression of Improvement, health-specific quality of life (EQ-visual analogue scale [EQ-VAS]), use of incontinence aids, and satisfaction with treatment. There was no face-to-face contact with the participants at any time. Analysis was based on intention-to-treat. We lost 32.4% (81/250) of participants to follow-up after 1 year and 38.0% (95/250) after 2 years. With both interventions, we observed highly significant (P < 0.001) improvements with large effect sizes (>0.8) for symptoms and condition-specific quality of life (QoL) after 1 and 2 years, respectively. No significant differences were found between the groups. The mean (sd) changes in symptom score were 3.7 (3.3) for the internet group and 3.2 (3.4) for the postal group (P = 0.47) after 1 year, and 3.6 (3.5) for the internet group and 3.4 (3.3) for the postal group (P = 0.79) after 2 years. The mean changes (sd) in condition-specific QoL were 5.5 (6.5) for the internet group and 4.7 the for postal group (6.5) (P = 0.55) after 1 year, and 6.4 (6.0) for the internet group and 4.8 (7.6) for the postal group (P = 0.28) after 2 years. The proportions of participants perceiving they were much or very much improved were similar in both intervention groups after 1 year (internet, 31.9% [28/88]; postal, 33.8% [27/80], P = 0.82), but after 2 years significantly more participants in the internet group reported this degree of improvement (39.2% [29/74] vs 23.8% [19/80], P = 0.03). Health-specific QoL improved significantly in the internet group after 2 years (mean change in EQ-VAS, 3.8 [11.4], P = 0.005). We found no other significant improvements in this measure. At 1 year after treatment, 69.8% (60/86) of participants in the internet group and 60.5% (46/76) of participants in the postal group reported that they were still satisfied with the treatment result. After 2 years, the proportions were 64.9% (48/74) and 58.2% (46/79), respectively. Non-face-to-face treatment of SUI with PFMT provides significant and clinically relevant improvements in symptoms and condition-specific QoL at 1 and 2 years after treatment.