NCT05853822已完成不适用
FirmTech User Research Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Device satisfaction via Leikert scores
研究概览
简要总结
The objective of this study is to see whether a home-use penile constriction device, Firmtech Tech Ring, can be determined to be superior to the Giddy device through evaluation of Leikert scale scores to assess ease of use and participant comfort and satisfaction with erectile quality with these devices. The primary outcome will be the satisfaction with use of the device as assessed through the Leikert scores. The other outcomes will be secondary.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •All English-speaking participants > 18 years old recruited through social media.
- •Physically and emotionally capable of engaging in sexual activity with at least one attempt per week of masturbation or sexual intercourse
排除标准
- •Men who cannot understand English.
- •Men with a prior or current penile implant.
- •Transgender or non-binary individuals
- •Men diagnosed with a hidden or buried penis.
- •Investigator's impression of expected poor participant compliance or anatomic inadequacy (penile size/girth)
- •Any psychiatric disorder, which, in the opinion of the investigator, would prohibit participation.
- •Coagulopathy or other blood disorder which the investigator determines would affect the participant's participation in the trial.
- •Any tumor in the pelvic or penile region within the last 3 years
- •Men with an active caregiver who are unable to live independently.
- •Men who the provider is concerned would be at high risk for non-healing wounds of the penis.
- •Participants with sensory disorders like sensory processing disorder, sensory integration dysfunction disorder, neuropathies, etc.
结局指标
主要结局
Device satisfaction via Leikert scores
时间窗: 2 weeks after receiving device
A survey will be completed for each device after utilization
次要结局
未报告次要终点
研究者
研究点 (1)
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