Leal-García Jesica, Blanco-Giménez Paula, Jaenada-Carrillero Eloy, Martínez-Soler Marta, Huertas-Ramírez Borja, Mahiques-Sanchis Alex, Vicente-Mampel Juan
Department of Physiotherapy, School of Medicine and Health Sciences, Catholic University of Valencia, 46001 Torrent, Valencia, Spain.
Healthcare (Basel). 2025 Jul 21;13(14):1759. doi: 10.3390/healthcare13141759.
Overactive bladder (OAB) and urinary incontinence (UI) are prevalent, particularly in older adults, and affect quality of life. OAB involves urgency, frequency, nocturia, and urgency incontinence, often linked to involuntary detrusor contractions. Treatment guidelines recommend a stepwise approach, starting with pelvic floor muscle training (PFMT), followed by pharmacological or minimally invasive therapies, such as neuromodulation. However, the combined effects of PFMT and neuromodulation have not been well established. This study aimed to evaluate the impact of combining pelvic floor exercises with neuromodulation versus PFMT with sham neuromodulation or standard physiotherapy after a 12-week intervention in individuals with OAB and UI. A double-blind, randomized controlled trial was designed with three groups: PFMT + neuromodulation, PFMT + sham, and conventional physiotherapy (control) in a 1:1:1 ratio. This study followed the CONSORT guidelines and was registered at ClinicalTrials.gov (NCT06783374). The sample size was calculated using GPower software, assuming a Cohen's effect size of 1.04, a power of 0.80, an alpha of 0.05, and a 15% dropout rate, totaling 63 participants (21 per group). Participants attended 24 sessions over 12 weeks (2 sessions per week). The interventions were based on previously validated protocols. The primary outcomes included health-related quality of life, pelvic floor muscle function, pain, adherence, and general health. The secondary outcomes included Incontinence Quality of Life questionnaire, 3-day bladder diary, International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form, kinesiophobia, and electromyographic data.
膀胱过度活动症（OAB）和尿失禁（UI）很常见，尤其是在老年人中，并且会影响生活质量。OAB包括尿急、尿频、夜尿症和急迫性尿失禁，通常与逼尿肌不自主收缩有关。治疗指南推荐采用逐步治疗方法，从盆底肌训练（PFMT）开始，随后是药物治疗或微创治疗，如神经调节。然而，PFMT和神经调节的联合效果尚未得到充分证实。本研究旨在评估在对患有OAB和UI的个体进行12周干预后，将盆底肌锻炼与神经调节相结合与PFMT加假神经调节或标准物理治疗相比的效果。设计了一项双盲随机对照试验，分为三组：PFMT + 神经调节组、PFMT + 假治疗组和传统物理治疗（对照组），比例为1:1:1。本研究遵循CONSORT指南，并在ClinicalTrials.gov（NCT06783374）注册。使用GPower软件计算样本量，假设科恩效应量为1.04，检验效能为0.80，α为0.05，失访率为15%，共63名参与者（每组21名）。参与者在12周内参加24次治疗（每周2次）。干预措施基于先前验证的方案。主要结局包括与健康相关的生活质量、盆底肌功能、疼痛、依从性和总体健康状况。次要结局包括尿失禁生活质量问卷、3天膀胱日记、国际尿失禁咨询委员会尿失禁简表问卷、运动恐惧症和肌电图数据。
