At-Home Neuromodulation for Female Sexual Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Number of dorsal genital nerve stimulation (DGS) sessions performed
研究概览
简要总结
This pilot study investigates the regular use of non-invasive dorsal genital nerve stimulation (DGS) for the treatment of female sexual dysfunction (FSD). The researchers aim to determine whether subjects with FSD can correctly follow an at-home treatment regimen and to demonstrate that DGS can improve FSD arousal symptoms in premenopausal and postmenopausal women. Some subjects will use a smart vibrator for comparison to DGS.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Capable of speaking and understanding English.
- •Able to comprehend the clinical study procedures and provide informed consent.
- •Identified as having female sexual dysfunction with a Female Sexual Function Index (FSFI) score of 26.55 or less and a score of 3 or less on one or more of the FSFI subdomains of lubrication, arousal, and orgasm.
- •Willing and able to adhere to the study protocol
- •Able to attend experimental sessions at Michigan Medicine at both the start and conclusion of the study.
排除标准
- •Not currently sexually active.
- •Pregnant or planning to get pregnant during the study period.
- •History of a neurological disorder or impairments affecting pelvic organ function, including diagnosed with dorsal genital nerve damage, lower motor dysfunction, or other related conditions.
- •Implanted with a neurostimulator for bladder or bowel function.
- •Have a skin condition that would predispose them to sensitivity to the stimulation electrodes.
- •Female sexual dysfunction limited solely to low desire, without issues in lubrication, arousal, or orgasm.
- •Clinically diagnosed bladder dysfunction, pelvic pain, or other pelvic organ symptoms; or a score of 8 or higher on the American Urological Association Symptom Index (AUASI).
- •Unable or unwilling to adhere to the study protocol
- •Simultaneously participating in another research study that may affect the results of this study.
结局指标
主要结局
Number of dorsal genital nerve stimulation (DGS) sessions performed
时间窗: Approximately day 22
Number of related adverse events
时间窗: Up to week 9
Study-related AEs include incidents such as device zapping, skin irritation, back cramps, or falls due to sitting for 30 minutes of stimulation.
次要结局
- Change in Female Sexual Function Index (FSFI) total scores(Baseline and approximately day 22)
- The Patient Global Impression of Change (PGIC) survey score(Up to week 9)
研究者
Timothy Bruns
Associate Professor of Biomedical Engineering
University of Michigan