A Pilot Study to Determine the Degree and Effectiveness of the Various Operating Modes of vSculpt on Enhancing Genital Blood Flow and Improving Quality of Life in Women Who Experience Sexual Dysfunction and Stress Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Joylux, Inc.
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Change in Blood Flow as Measured by Temperature Change in the Genitalia Using Thermography Technology
研究概览
简要总结
A pilot study to determine the degree and effectiveness of the various modes of vSculpt, an over-the-counter "OTC" medical device, on enhanced genital blood flow and improvement in quality of life in menopausal women who suffer sexual dysfunction and stress incontinence
详细描述
The primary aim of this study is to determine the degree and effectiveness of the various modes of vSculpt on enhanced genital blood flow with menopausal women who experience sexual dysfunction and stress incontinence as measured by temperature change in the genitalia immediately after initial and final treatment and an improvement in quality of life after using the vSculpt device over the course of four weeks. The secondary aim is to compare the differences in genital blood flow and improvement in quality of life of vSculpt's various modes against Intone, another over-the-counter "OTC" medical device that utilizes a different technology to treat stress incontinence and improve sexual dysfunction.
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
- None
入排标准
- 年龄范围
- 48 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Study participants will be female
- •Female participants who are capable of giving informed consent
- •Female participants who are menopausal who have not had a menses within one year, and are within the ages of 48 and 60
- •Female participants who have had one or more vaginal births
- •Female participants who are currently engaged in vaginal sexual intercourse with a partner
- •Female participants who are presently experiencing bladder control issues either leakage, frequency or urgency
- •Female participants who are presently experiencing pain during sexual intercourse
排除标准
- •Female participants shall not have an active sexually transmitted disease and/or infection
- •Female participants who are actively undergoing chemotherapy
- •Female participants who are currently taking any cancer-related drugs
- •Female participants who are breastfeeding or lactating
- •Female participants who have a medical history of neurological disorders (e.g., multiple sclerosis, Parkinson's disease)
- •Female participants with an active urinary tract infection (UTI)
- •Female participants with active bladder stones
- •Female participants with active bladder tumor(s)
- •Females with prior laser or vaginal rejuvenation surgeries or treatments
- •Females with a medical history of vaginal cancer or radiation or surgery with exception of related to childbirth
- •Females with prior non-invasive treatments (estrogen cream) or pelvic floor physical therapy for the vaginal area/ pelvic floor in the past six month
- •Females with a physical disability precluding her from holding a lithotomy for an hour
- •Females who are homeless
结局指标
主要结局
Change in Blood Flow as Measured by Temperature Change in the Genitalia Using Thermography Technology
时间窗: Pre and post treatment at baseline and pre and post treatment at day 30
The primary outcomes assessed will be change in blood flow as measured by temperature change in Celsius in the genitalia using thermography technology.
次要结局
- Patient Quality of Life as Measured by the Incontinence Impact Questionnaire, Short Form (IIQ-7)(Baseline and 30 days)
- Patient Quality of Life as Measured by Female Sexual Distress Scores (FSDS) at Baseline and 30 Days Post Treatment.(Baseline and 30 days)
- Patient Quality of Life as Measured by Female Sexual Function Index (FSFI) Scores at Baseline and 30 Days Post Treatment.(Baseline and 30 days)
- Patient Quality of Life as Measured by the Urogenital Distress Inventory, Short Form (UDI-6)(Baseline and 30 days)