Pilot Study Examining Feasibility and Effects of Physiotherapy Treatment Compared to Standard Usual Care in Gynecological Cancer Survivors with Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Adherence rates
研究概览
简要总结
The aims of this pilot study are to examine the feasibility and to explore the effects of a physiotherapy treatment compared to standard usual care in gynecological cancer survivors with urinary incontinence in preparation of a large randomized controlled study.
详细描述
Epidemiological studies demonstrated a growing number of gynecological cancer survivors, and this population is at great risk of developing pelvic floor dysfunction after cancer and its treatment. Representing the most prevalent pelvic floor dysfunction, urinary incontinence affects up to 70% of gynecological cancer survivors. International practice guidelines, in line with available meta-analysis, recommend physiotherapy as a first-line treatment to reduce urinary incontinence. However, there is limited evidence on its effectiveness in gynecological cancer survivors. Considering the current knowledge and the negative impacts of urinary incontinence, there is an urgent need to examine whether this population can benefit from this intervention in a pilot study, to conduct eventually a larger randomized controlled trial. The objectives of the present study are to examine the feasibility and to explore the effects of a physiotherapy treatment compared to standard usual care in gynecological cancer survivors with urinary incontinence. A total of 44 participants will be randomized to receive either physiotherapy or standard usual care (wait-list for physiotherapy). Baseline and post-treatment evaluations will be realized by a physiotherapist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •History of gynecological cancer (endometrial, cervical, vaginal or other parts of the uterus)
- •Scheduled oncological treatments completed
- •Stress or mixed urinary incontinence with a frequency of at least three urinary leakage per
排除标准
- •Pelvic floor rehabilitation in the last year
- •Other conditions interfering with assessment
结局指标
主要结局
Adherence rates
时间窗: Baseline to 2-week post-treatment evaluation
To determine acceptability by assessing adherence to exercises.
Retention rate
时间窗: Baseline to 2-week post-treatment evaluation
To determine feasibility by evaluating attrition.
次要结局
- Change from baseline in pelvic floor muscle morphometry(Baseline to 2-week post-treatment evaluation)
- Change from baseline in symptoms of pelvic floor dysfunction(Baseline to 2-week post-treatment evaluation)
- Change from baseline in pelvic floor muscle function(Baseline to 2-week post-treatment evaluation)
- Change from baseline in number of urinary leaks(Baseline to 2-week post-treatment)
- Change from baseline in sexual function(Baseline to 2-week post-treatment evaluation)
- Change from baseline in quality of life(Baseline to 2-week post-treatment evaluation)
- Patient's global impression of change(Baseline to 2-week post-treatment evaluation)
- Rate of adverse events(Baseline to 2-week post-treatment evaluation)
研究者
Mélanie Morin
Researcher and Associate Professor
Université de Sherbrooke