An Open-label Long-term Evaluation of a Novel Intravaginal Device in Female Patients Experiencing Sexual and Bladder Function Issues
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Joylux, Inc.
- 入组人数
- 65
- 试验地点
- 4
- 主要终点
- Improvement in Patient Quality of Life as Measured by Female Sexual Response Index
研究概览
简要总结
An open-label long-term evaluation of a novel intravaginal device in female patients experiencing sexual and bladder function issues.
详细描述
To determine the long-term clinical efficacy of the vSculpt therapy on treating the pelvic floor area and vaginal tissue for females who experience bladder and sexual dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All study participants are required to be biological females (genotype XX) to participate
- •Female participants will be of adult age, over 18
- •Female participants with self-reported concerns with bladder and sexual function
- •Female participants who have reliable and consistent computer and internet access on a daily basis
排除标准
- •Female participants shall not have an active sexually transmitted disease and/or infection
- •Female participants who are actively undergoing chemotherapy or radiation
- •Female participants who are currently taking any cancer-related or photosensitivity drugs
- •Female participants who are pregnant, who may think they are pregnant, and/or actively trying to get pregnant during the clinical study
研究组 & 干预措施
vSculpt, model #VS1100
A novel intravaginal device for females
干预措施: vSculpt (Device)
结局指标
主要结局
Improvement in Patient Quality of Life as Measured by Female Sexual Response Index
时间窗: 365 days
Improvement in patient quality of life as measured by an improvement in Female Sexual Function Index (FSFI) scores.
Improvement in patient quality of life as measured by the Female Sexual Distress
时间窗: 365 days
Improvement in patient quality of life as measured by an improvement Female Sexual Distress Score (FSDS) scores.
Improvement in patient quality of life as measured by the Urogenital Distress Inventory, Short Form (UDI-6)
时间窗: 365 days
Improvement in patient quality of life as measured by an improvement Urogenital Distress Inventory, Short Form (UDI-6) scores.
Improvement in patient quality of life as measured by the Incontinence Impact Questionnaire, Short Form (IIQ-7)
时间窗: 365 days
Improvement in patient quality of life as measured by an improvement Incontinence Impact Questionnaire, Short Form (IIQ-7) scores.
次要结局
未报告次要终点