Nakib Nissrine, Sutherland Suzette, Hallman Kevin, Mianulli Marcus, R Boulware David
Department of Urology, University of Minnesota, Minneapolis, MN, USA.
Department of Urology, University of Washington, Seattle, WA, USA.
Ther Adv Urol. 2024 Feb 6;16:17562872241228023. doi: 10.1177/17562872241228023. eCollection 2024 Jan-Dec.
Stress urinary incontinence (SUI) presents as unintentional urine leakage associated with activities. It significantly affects quality of life (QoL) and is the most common type of incontinence in women. Current treatment options, particularly non-surgical therapies, are lacking.
To assess the efficacy of mechanotherapy provided by the Flyte intra-vaginal device during pelvic floor muscle training (PFMT).
This was a randomized, controlled, double-blinded trial.
Flyte is a repeat use device for conditioning and strengthening the pelvic floor muscles (PFMs). It provides two-part mechanotherapy. Part 1 is the stretching and preloading of the PFM from the internal wand. Part 2 integrates mechanical pulses which elicit muscle cellular and tissue level responses that trigger cellular regeneration, improve neuromuscular facilitation and motor learning. Subjects used the device for 5 min/day for 12 weeks. Subjects (144) were randomized and evaluated at 6 and 12 weeks. Arm A (72) received both Part 1 and Part 2 mechanotherapy for 12 weeks, whereas Arm B (72) received Part 1 therapy for 6 weeks, then crossed over to full therapy. Mean age was 50, 49, respectively, prior pelvic/abdominal surgery 26%, 46%, and previous incontinence treatments 13%, 22%. The primary endpoint was 24-h pad weight (24-HR PW) at 6 weeks. Secondary endpoints were 24-HR PW at 12 weeks and QoL [International Consultation on Incontinence Questionnaire (ICIQ), Urinary Incontinence Quality of Life (IQOL)].
Part 1 therapy had a greater than anticipated therapeutic effect. Thus, the study was underpowered to identify differences between study arms. Therefore, data were pooled to assess the effects of mechanotherapy. Twenty four-HR PW was significantly reduced at 6 weeks ( = <0.0001), with further reduction from 6 to 12 weeks ( = <0.0001). Data were stratified based on 24-HR PW severity. Significant reductions were noted in all severity groups (mild = <0.0001, moderate = <0.0001, severe = <0.01). QoL was similarly improved at 6 weeks (ICIQ = <0.0001, IQOL = <0.0001), and 12 weeks (ICIQ = <0.0001, IQOL = <0.0001). Compliance was >80% at 6 weeks and 70% at 12 weeks.
Two-part mechanotherapy significantly improved 24-HR PW and QoL across all severities of SUI. Improvements were noted in as little as 2 weeks and appeared to be sustained through 2-year follow up.
Registered on ClinTrials.gov (NCT02954042).
压力性尿失禁（SUI）表现为与活动相关的无意尿液泄漏。它严重影响生活质量（QoL），是女性中最常见的尿失禁类型。目前的治疗选择，尤其是非手术疗法，较为匮乏。
评估Flyte阴道内装置在盆底肌训练（PFMT）期间提供的机械疗法的疗效。
这是一项随机、对照、双盲试验。
Flyte是一种用于调节和强化盆底肌肉（PFMs）的可重复使用装置。它提供两部分机械疗法。第1部分是通过内部棒对盆底肌进行拉伸和预加载。第2部分整合了机械脉冲，可引发肌肉细胞和组织水平的反应，从而触发细胞再生、改善神经肌肉促进作用和运动学习。受试者每天使用该装置5分钟，持续12周。受试者（144名）被随机分组，并在6周和12周时进行评估。A组（72名）接受第1部分和第2部分机械疗法，为期12周，而B组（72名）接受第1部分疗法6周，然后交叉接受完整疗法。平均年龄分别为50岁和49岁，既往盆腔/腹部手术史分别为26%和46%，既往尿失禁治疗史分别为13%和22%。主要终点是6周时的24小时护垫重量（24-HR PW）。次要终点是12周时的24-HR PW和生活质量[尿失禁咨询国际问卷（ICIQ）、尿失禁生活质量（IQOL）]。
第1部分疗法的治疗效果大于预期。因此，该研究的效能不足以识别研究组之间的差异。因此，将数据汇总以评估机械疗法的效果。24-HR PW在6周时显著降低（P = <0.0001），从6周至12周进一步降低（P = <0.0001）。数据根据24-HR PW严重程度进行分层。所有严重程度组均有显著降低（轻度P = <0.0001，中度P = <0.0001，重度P = <0.01）。生活质量在6周时同样得到改善（ICIQ P = <0.0001，IQOL P = <0.0001），12周时也是如此（ICIQ P = <0.0001，IQOL P = <0.0001）。6周时的依从性>80%，12周时为70%。
两部分机械疗法在SUI的所有严重程度上均显著改善了24-HR PW和生活质量。在短短2周内就有改善，并且在2年的随访中似乎持续存在。
在ClinicalTrials.gov上注册（NCT02954042）。
