Sjöström Malin, Umefjord Göran, Stenlund Hans, Carlbring Per, Andersson Gerhard, Samuelsson Eva
Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.
Department of Psychology, Stockholm University, Stockholm, Sweden.
BJU Int. 2015 Dec;116(6):955-64. doi: 10.1111/bju.13091. Epub 2015 Jun 3.
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.
评估基于盆底肌训练(PFMT)的两种非面对面压力性尿失禁(SUI)治疗方案的长期效果。
本研究为一项随机对照试验,通过网络招募了250名年龄在18 - 70岁、每周至少出现一次SUI的社区女性。诊断基于经过验证的自我评估问卷、2天膀胱日记以及与尿失禁治疗师的电话访谈。通过连续计算机生成的区组随机化,由独立管理员将患者分配至接受为期3个月的基于互联网的治疗方案(n = 124)或邮寄治疗方案(n = 126)。两种干预措施均主要聚焦于PFMT。互联网组接受尿失禁治疗师的持续电子邮件支持,而邮寄组则自行训练。在1年和2年后通过自我评估邮寄问卷进行随访。主要结局指标为症状严重程度(国际尿失禁咨询问卷简表[ICIQ - UI SF])和特定疾病生活质量(ICIQ - 下尿路症状生活质量[ICIQ - LUTSqol])。次要结局指标包括患者总体改善印象、健康相关生活质量(EQ - 视觉模拟量表[EQ - VAS])、失禁辅助器具的使用以及对治疗的满意度。在任何时候都未与参与者进行面对面接触。分析基于意向性治疗原则。
1年后,我们失去了32.4%(81/250)的参与者进行随访,2年后失去了38.0%(95/250)。两种干预措施下,分别在1年和2年后,我们观察到症状和特定疾病生活质量(QoL)均有高度显著(P < 0.001)的改善,效应量较大(>0.8)。两组之间未发现显著差异。1年后,互联网组症状评分的平均(标准差)变化为3.7(3.3),邮寄组为3.2(3.4)(P = 0.47);2年后,互联网组为3.6(3.5),邮寄组为3.4(3.3)(P = 0.79)。特定疾病QoL的平均变化(标准差)在1年后,互联网组为5.5(6.5),邮寄组为4.7(6.5)(P = 0.55);2年后,互联网组为6.4(6.0),邮寄组为4.8(7.6)(P = 0.28)。1年后,两个干预组中认为自己有很大或非常大改善的参与者比例相似(互联网组,31.9%[28/88];邮寄组,33.8%[27/80],P = 0.82),但2年后,互联网组报告有此程度改善的参与者明显更多(39.2%[29/74]对23.8%[19/80],P = 0.03)。2年后,互联网组的健康相关生活质量有显著改善(EQ - VAS平均变化,3.8[11.4],P = 0.005)。我们在该指标上未发现其他显著改善。治疗1年后,互联网组69.8%(60/86)的参与者和邮寄组60.5%(46/76)的参与者报告他们对治疗结果仍满意。2年后,这一比例分别为64.9%(48/74)和58.2%(46/79)。
采用PFMT对SUI进行非面对面治疗在治疗后1年和2年时,症状和特定疾病QoL有显著且具有临床意义的改善。