Pelvic Physiotherapy in the Prevention of Vaginal Stenosis Secondary to Radiotherapy of Gynecological Cancer: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Vaginal Stenosis
研究概览
简要总结
Vaginal stenosis is one of the most prevalent side effects of pelvic radiation, affecting about one third of women. In this randomized controlled trial, the effect of a pelvic physiotherapy protocol on an incidence rate of vaginal stenosis in women with gynecological cancer undergoing gynecological brachytherapy. In addition, the investigators will explore an improvement in quality of life, sexuality, and contractile function of the pelvic floor muscles.
详细描述
Tis study will be conducing in a reference hospital to oncology treatment were mane patients with gynecologic cancer are management on radiotherapy services. The aim of this work is evaluated the effects of the pelvic physiotherapy (PP) on the more prevalent constriction pathology (vaginal stenosis) secondary to the brachytherapy. The PP will be conduced by three months after the radiotherapy starts and the incidence of the vaginal stenosis will be compared with a control group throughout six months of fallow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women over 18 years old;
- •No vaginal stenosis at first evaluation;
- •Women free of previous intracavitary radiation;
- •Women diagnosed with gynecological cancer who are undergoing brachytherapy treatment during the period of research at the Santa Rita Hospital of the Santa Casa de Misericórdia in Porto Alegre;
- •Women who agree to participate in the research through the Informed Consent Form (TCLE).
排除标准
- •Women who do not sign the ICF;
- •Women not being treated for gynecological cancer;
- •Women who have a 30% lack of physical therapy sessions (4 sessions);
- •Women who present complications that prevent the accomplishment of the protocol of pelvic physiotherapy or that do not perform all the treatment with brachytherapy.
研究组 & 干预措施
Pelvic physiotherapy (PP)
Pelvic Physiotherapy include daily pelvic floor muscle training (PFMT). PFMT starts at first session of the brachytherapy and will be conduced during the twelve weeks treatment.
干预措施: Pelvic Physiotherapy (Behavioral)
Pelvic physiotherapy (PP)
Pelvic Physiotherapy include daily pelvic floor muscle training (PFMT). PFMT starts at first session of the brachytherapy and will be conduced during the twelve weeks treatment.
干预措施: Standard care (SC) (Behavioral)
Stander Care (SC)
The stander care (SC) includes a guideline for gynecological cancer patients under radiotherapy/brachytherapy: 1) daily vaginal dilator therapy (10 to 15 minutes); and 2) usual care management. This SC starts at first session of the brachytherapy and will be conduced during the twelve weeks treatment.
干预措施: Standard care (SC) (Behavioral)
结局指标
主要结局
Vaginal Stenosis
时间窗: With completion of the study, predicted 15 months after the start of the study.
Vaginal stenosis will be evaluated before the first brachytherapy and twelve months after. Considered according to the study of Kirchheiner et al., (2016) that used the Common Terminology Criteria for Adverse Events (CTCAE v3.0). Vaginal stenosis will also be considered as the narrowing of the vaginal canal that makes it impossible to introduce the number 1 acrylic gynecological speculum through the vaginal introitus.
次要结局
- Sexuality(With completion of the study, predicted 15 months after the start of the study.)
- Quality of life(With completion of the study, predicted 15 months after the start of the study.)
- Muscle activity and contractile function of the pelvic floor(With completion of the study, predicted 15 months after the start of the study.)
研究者
Fabrício Edler Macagnan
Doctor
Federal University of Health Science of Porto Alegre