FemmeJock: A Pilot Study to Assess Patient Satisfaction and Improvement of Pelvic Floor Symptoms Using a Pelvic Floor Support Girdle in Women With Uterovaginal Prolapse.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- to assess patient satisfaction and continuation of use of the FemmeJock support system after 3 months of treatment.
研究概览
简要总结
FemmeJock is a pelvic floor support system developed by pelvic floor physiotherapists for patients with pelvic organ prolapse in order to ameliorate symptoms of pelvic floor pressure and discomfort. The device is a girdle to be worn on the outside of underwear. The device is machine washable and there are no documented risks with wearing it. This product is currently being used by pelvic floor physiotherapists and has been subjectively reported by individual accounts as being successful in improving pelvic floor symptoms. The efficacy of this product has not been previously studied in women with pelvic organ prolapse. The investigators are proposing a pilot study with the following specific aims:
- to assess patient satisfaction and continuation of use of the FemmeJock support system after 3 months of treatment.
- to describe, if any, the reasons for discontinuation associated with the use of this product, and
- to assess whether women experience improvement of pelvic floor symptoms after using this product.
详细描述
This will be a prospective pilot study in order to determine the efficacy and tolerability of FemmeJock in patients with pelvic organ prolapse. We plan to enroll 30 patients who will be recruited from the OU Health Science Center. We will offer study participation to patients who meet the inclusion criteria listed below, and who are: (1) awaiting surgical management and desire a temporary nonsurgical option, (2) seeking permanent nonsurgical treatment, or (3) who have a contraindication to surgical management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pelvic organ prolapse, > stage II
- •1 or more prolapse associated symptoms:
- •Herniation symptoms
- •Pelvic pressure
- •Bulging tissue
- •Sexual dysfunction
- •Patient willingness to enroll
- •Available for 3 months of follow-up
排除标准
- •Pregnancy or planning pregnancy within the next 3 months
- •Perineal ulcers or trauma
- •Anticipating relocation in next 3 months
- •Current pessary use
- •Dementia or inability to complete questionnaires
- •Chronic inflammatory or infectious vulvar condition (i.e., dermatologic conditions: lichen sclerosis or lichen planus, or vulvar candidiasis)
结局指标
主要结局
to assess patient satisfaction and continuation of use of the FemmeJock support system after 3 months of treatment.
时间窗: 2 years
次要结局
- To assess whether women experience improvement of pelvic floor symptoms after using this product.(2 years)
- To describe, if any, the reasons for discontinuation associated with the use of this product.(2 years)