Melbourne School of Health Sciences, The University of Melbourne, 161 Barry Street, Parkville, VIC, 3010, Australia.
Allied Health Research, The Royal Women's Hospital Melbourne, 20 Flemington Rd, Parkville, VIC, 3052, Australia.
BMC Womens Health. 2024 Sep 27;24(1):529. doi: 10.1186/s12905-024-03365-9.
Urinary incontinence (UI) is the most prevalent pelvic floor disorder following treatment for gynaecological cancer with a distressing impact on quality-of-life in survivors. Physiotherapist-supervised pelvic floor muscle (PFM) training is recommended as the first-line intervention for UI in community-dwelling women. However, it is not known if this intervention is effective in women following treatment for gynaecological cancer, nor whether PFM training can be delivered entirely remotely. The primary aim of this study is to investigate if a telehealth-delivered PFM training program incorporating a novel biofeedback device reduces UI compared with usual care, following gynaecological cancer.
This is a pragmatic, two-arm parallel-group, stratified superiority randomised controlled trial recruiting 72 participants (ACTRN12622000580774). Recruitment sites include gynaecology-oncology outpatient clinics, supplemented by advertisements through community foundations/social media/care groups. Participants must have completed primary cancer treatment at least 6 months prior or adjuvant therapy at least 3 months prior, for Stage I, II or III uterine, cervical, fallopian tube, primary peritoneal or ovarian cancer or borderline ovarian tumour, and have UI occurring at least weekly. Participants randomised to the usual care group will receive bladder and bowel advice handouts and one audio telehealth physiotherapist consultation to answer any queries about the handouts. Participants randomised to the intervention group will receive the same handouts plus eight video telehealth physiotherapist consultations for PFM training with a biofeedback device (femfit), alongside a home-based program over 16 weeks. The primary outcome measure is a patient-reported outcome of UI frequency, amount and interference with everyday life (measured using the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form), immediately post-intervention compared with baseline. Secondary outcomes include quality-of-life measures, bother of pelvic floor symptoms, leakage episodes, use of continence pads and global impression of change. We will also investigate if the intervention improves intra-vaginal resting and squeeze pressure in women in the intervention arm, using data from the biofeedback device.
If clinical effectiveness of telehealth-delivered physiotherapist-supervised PFM training, supplemented with home biofeedback is shown, this will allow this therapy to enter pathways of care, and provide an evidence-based option for treatment of post-cancer UI not currently available.
Australian New Zealand Clinical Trials Registry (ANZCTR), ID 12622000580774. Registered 20 April 2022.
尿失禁（UI）是妇科癌症治疗后最常见的盆底障碍，对幸存者的生活质量有令人痛苦的影响。物理治疗师监督的盆底肌肉（PFM）训练被推荐为社区居住女性 UI 的一线干预措施。然而，尚不清楚该干预措施是否对妇科癌症治疗后的女性有效，也不知道是否可以完全远程进行 PFM 训练。本研究的主要目的是调查在妇科癌症治疗后，使用结合新型生物反馈设备的远程医疗提供的 PFM 训练计划是否与常规护理相比减少了 UI。
这是一项实用的、双臂平行组、分层优势随机对照试验，招募了 72 名参与者（ACTRN12622000580774）。招募地点包括妇科肿瘤门诊，辅以通过社区基金会/社交媒体/护理小组发布的广告。参与者必须在至少 6 个月前完成主要癌症治疗或至少 3 个月前完成辅助治疗，用于 I 期、II 期或 III 期子宫、宫颈、输卵管、原发性腹膜或卵巢癌或交界性卵巢肿瘤，并且每周至少发生一次 UI。随机分配到常规护理组的参与者将收到膀胱和肠道建议手册，并进行一次音频远程医疗物理治疗师咨询，以回答手册相关的任何问题。随机分配到干预组的参与者将收到相同的手册以及八次视频远程医疗物理治疗师咨询，用于 PFM 训练和生物反馈设备（ femfit ），以及在 16 周内进行家庭为基础的方案。主要结局指标是患者报告的 UI 频率、数量和日常生活干扰的结果（使用国际尿失禁咨询问卷 - 尿失禁简短问卷测量），与基线相比，干预后立即测量。次要结局包括生活质量指标、盆底症状的困扰、漏尿发作、使用失禁垫和总体印象变化。我们还将使用生物反馈设备的数据，调查干预是否改善了干预组中女性的阴道静息和挤压压力。
如果远程医疗提供的物理治疗师监督的 PFM 训练，辅以家庭生物反馈的临床效果得到证实，这将使这种治疗方法进入护理途径，并为目前不可用的癌症后 UI 治疗提供一种基于证据的选择。
澳大利亚新西兰临床试验注册中心（ANZCTR），ID 12622000580774。2022 年 4 月 20 日注册。
