Reis Bianca Manzan, da Silva Jordana Barbosa, Rocha Ana Paula Rodrigues, Liebano Richard Eloin, Driusso Patricia
Women's Health Research Laboratory, Physical Therapy Post-Graduate Program, Federal University of São Carlos, Rod. Washington Luis, km 235, CEP, São Carlos, SP, 13565-905, Brazil.
Physioterapeutics Resources Laboratory, Physical Therapy Post-Graduate Program, Federal University of São Carlos, São Carlos, SP, Brazil.
Trials. 2021 Nov 20;22(1):823. doi: 10.1186/s13063-021-05781-w.
Pelvic floor muscle training (PFMT) exercises and neuromuscular electrical stimulation (NMES) are described as conservative interventions to prevent or treat female stress urinary incontinence (SUI). However, it has not been described yet the effect of PFMT associated to intravaginal NMES which evaluated the cost-effectiveness and cost-utility of treating.
To evaluate the effects of intravaginal NMES associated with the PFMT protocol on urinary loss and quality of life in women with SUI and to evaluate the cost-effectiveness and cost-utility and pelvic floor muscle in women with SUI.
Randomized controlled trial study with economic evaluation. Inclusion criteria are woman (biological), aged ≥ 18 years old and with a report of SUI ≥ once/week. Exclusion criteria are presence of vaginal or urinary infection, virginity, being in the gestational or puerperium period, or neurological disease. Participants will undergo physical therapy assessment and intervention: anamnesis, pelvic floor muscle assessment by vaginal palpation and manometry (Peritron), questionnaires (Short-Form 6 Dimensions-Brazil (SF-6D), King's Health Questionnaire (KHQ) and King´s Health Questionnaire for Scoring Algorithm), health costs, and voiding diary. Participants will be randomly allocated into 3 groups: CG (control group), IG 1 (intervention group 1, PFMT), and IG2 (intervention group 2, PFMT + NMES). The statistical analysis will be performed by intention to treat, and multivariate analysis of mixed effects will be used to compare outcomes. Effect size measurements will be calculated and will be provided by Cohen's d test. A significance level of 5% will be adopted. Additionally, the incremental cost-effectiveness and incremental cost-utility ratios will be used.
This protocol can corroborate with the literature in order to identify the effect of techniques, based on the possibility of confirming the hypothesis that the NMES associated with PFMT performed concurrently will be the best treatment option; considering the effectiveness, cost-effectiveness, and cost-utility analysis, it will be used as an option for optimization of the treatment of SUI.
Brazilian Registry of Clinical Trials (ReBEC) ID: RBR-6gtzg4 . Registered on September 3, 2019.
盆底肌训练（PFMT）和神经肌肉电刺激（NMES）被描述为预防或治疗女性压力性尿失禁（SUI）的保守干预措施。然而，尚未描述与阴道内NMES相关的PFMT的效果，该研究评估了治疗的成本效益和成本效用。
评估与PFMT方案相关的阴道内NMES对SUI女性尿失禁和生活质量的影响，并评估SUI女性的成本效益、成本效用和盆底肌情况。
进行随机对照试验研究并进行经济评估。纳入标准为年龄≥18岁且每周有≥1次SUI报告的女性（生物学意义上）。排除标准为存在阴道或泌尿系统感染、处女、处于妊娠期或产褥期或患有神经系统疾病。参与者将接受物理治疗评估和干预：问诊、通过阴道触诊和压力测定法（Peritron）进行盆底肌评估、问卷调查（巴西简短健康调查问卷6维度版（SF-6D）、国王健康问卷（KHQ）以及用于评分算法的国王健康问卷）、健康成本以及排尿日记。参与者将被随机分为3组：CG（对照组）、IG 1（干预组1，PFMT）和IG2（干预组2，PFMT + NMES）。统计分析将按意向性分析进行，混合效应多变量分析将用于比较结果。将计算效应量测量值，并通过科恩d检验提供。将采用5%的显著性水平。此外，将使用增量成本效益比和增量成本效用比。
该方案可以与文献相互印证，以便基于确认同时进行的与PFMT相关的NMES将是最佳治疗选择这一假设的可能性来确定技术效果；考虑到有效性、成本效益和成本效用分析，它将被用作优化SUI治疗的一种选择。
巴西临床试验注册中心（ReBEC）编号：RBR-6gtzg4。于2019年9月3日注册。
