The Efficacy of Pelvic Floor Muscle Training in Gynecological Cancer Survivors: A Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Urinary incontinence
研究概览
简要总结
A randomized controlled trial pilot study to test the efficacy of a pelvic muscular training intervention led by a physiotherapist on urinary incontinence, quality of life and sexual health in women who report urinary urgency and incontinence following surgery and radiation treatment for gynecological cancer vs. usual care (a 1-page sheet on Kegel exercises).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •treated with surgery and adjuvant treatment, including radiation, for gynecological cancer within the last 3 years
排除标准
- •stage IV cancer or stage III and IV cervical cancer
- •radiation not part of treatment
- •known spinal or long bone metastases diagnosis with a neuromuscular disorder that may impact pelvic floor muscle function
- •urinary incontinence issues prior to cancer diagnosis
- •scheduled or previous surgical treatment of incontinence
- •fecal incontinence
- •body mass index (BMI) > 35
- •use of medications to improve bladder function
- •unable to complete questionnaires in English or unable to actively participate in physiotherapy treatment provided in English.
研究组 & 干预措施
Training
Pelvic floor muscle training delivered by a physiotherapist with clinical expertise and training in treating pelvic floor dysfunction
干预措施: Training (Other)
Usual Care Control
Participants randomized to this arm will receive a 1-page educational pamphlet on pelvic floor muscle training, specifically Kegel exercises, which is equivalent to current standard care. Individuals randomized to this group will be placed on the clinic waiting list and be eligible for treatment following completion of the 12 week (end of study) measures.
干预措施: Usual Care (Other)
结局指标
主要结局
Urinary incontinence
时间窗: 12 weeks
Urinary incontinence, measured using the International Consultation on Incontinence Questionnaire Urinary Incontinence (ICIQ-UI Short Form) and bladder diary
次要结局
未报告次要终点