Effect of Peripheral Neuromodulation on Vaginal Blood Flow
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Percent Change in Average Vaginal Pulse Amplitude (VPA) During Stimulation From the Average Baseline Value
研究概览
简要总结
The researchers want to see if nerve stimulation interventions cause a change in vaginal blood flow. This intervention was performed in women who have neurogenic (spinal cord injury) or non-neurogenic sexual dysfunction and healthy women.
详细描述
Two nerve stimulation locations (genital nerve and tibial nerve) were targeted with skin-surface electrical stimulation in separate experimental sessions.
This study was designed as a crossover study, but all participant data was analyzed together due to small enrollment size.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Non-dysfunction participants, no spinal cord injury
- •Inclusion Criteria:
- •Adult (over 18 years old) cis-gender female
- •Neurologically stable
- •Sexually active at least once per month
- •Able to consent and communicate effectively with research team
排除标准
- •Pregnancy or planning to become pregnant during study period
- •Sexual dysfunction, per short-form Female Sexual Function Index (FSFI) score below 19
- •Lubrication difficulties, per short-form FSFI lubrication subdomain score below or equal to 4
- •Clinically diagnosed bladder dysfunction, pelvic pain, or other pelvic organ symptoms
- •Suspected or diagnosed epilepsy
- •Active infection or active pressure sores in the perineal region
- •Implanted pacemaker, defibrillator, spinal cord stimulator, or other nerve stimulator
- •Currently has or tested positive in the last 14 days for COVID-19 or is symptomatic for COVID-
- •Sexual dysfunction participants, non- spinal cord injury
- •Inclusion Criteria:
- •Adult (over 18 years old) cis-gender female
- •Neurologically stable
- •Sexually active at least once per month
- •Sexual dysfunction, per short-form FSFI score below 19
- •Lubrication difficulties, per short-form FSFI lubrication subdomain score below or equal to 3
- •Able to understand consent and communicate effectively with research team
- •Exclusion Criteria:
- •Pregnancy or planning to become pregnant during study period
- •Clinically diagnosed bladder dysfunction, pelvic pain, or other pelvic organ symptoms
- •Active infection or active pressure sores in the pelvic region
- •Implanted pacemaker or defibrillator
- •Currently has or tested positive in the last 14 days for COVID-19 or is symptomatic for COVID-
- •Sexual dysfunction participants with spinal cord injury
- •Inclusion Criteria:
- •Adult (over 18 years old) cis-gender women
- •Clinically diagnosed spinal cord injury (AIS A-B) at vertebral level within C6-T10 at least six months prior or clinically diagnosed spinal cord injury (AIS C) at vertebral level within C4-T10 at least six months prior
- •Nominally sexually active, but at minimum interest in sexual pleasure even if fully self-induced
- •Sexual dysfunction, per short-form FSFI score below 19
- •Able to understand consent and communicate effectively with research team
- •Exclusion Criteria:
- •Spinal cord injury at or above C5 level (C1-C5) if AIS A or B, or spinal cord injury at or above C3 level (C1-C3) if AIS C
- •Spinal cord injury below T10 vertebral level or reflexes not preserved
- •Acute worsening in motor or sensory function in the last month
- •Suspected or diagnosed epilepsy
- •Pregnancy or planning to become pregnant during study period
- •Active infection or active pressure sores in the perineal region
- •Implanted pacemaker or defibrillator
- •Currently has or tested positive in the last 14 days for COVID-19 or is symptomatic for COVID-19.
研究组 & 干预措施
Tibial nerve stimulation then Genital nerve stimulation
Participants who began the study with the tibial nerve stimulation and then proceeded to genital nerve stimulation
Electrical stimulation applied to target the tibial nerve on one leg, with electrodes above the malleolus and on the bottom of the foot
干预措施: Transcutaneous electrical nerve stimulation - Tibial Nerve (Device)
Tibial nerve stimulation then Genital nerve stimulation
Participants who began the study with the tibial nerve stimulation and then proceeded to genital nerve stimulation
Electrical stimulation applied to target the tibial nerve on one leg, with electrodes above the malleolus and on the bottom of the foot
干预措施: Transcutaneous electrical nerve stimulation - Genital Nerve (Device)
Genital nerve stimulation then Tibial nerve stimulation
Participants who began the study with the genital nerve stimulation and then proceeded to tibial nerve stimulation
Electrical stimulation applied to target the genital nerve, with electrodes on either side of the clitoris.
干预措施: Transcutaneous electrical nerve stimulation - Tibial Nerve (Device)
Genital nerve stimulation then Tibial nerve stimulation
Participants who began the study with the genital nerve stimulation and then proceeded to tibial nerve stimulation
Electrical stimulation applied to target the genital nerve, with electrodes on either side of the clitoris.
干预措施: Transcutaneous electrical nerve stimulation - Genital Nerve (Device)
结局指标
主要结局
Percent Change in Average Vaginal Pulse Amplitude (VPA) During Stimulation From the Average Baseline Value
时间窗: Test baseline (approximately minute 0) up to Test completion (approximately minute 60)
VPA will be measured by a vaginal plethysmography transducer. A sensor placed in the vagina will measure changes in blood flow.
次要结局
- Percent Change in Heart Rate After Stimulation From Baseline(Test baseline (approximately minute 0) up to Test completion (approximately minute 60))
- Percent Change in Mean Arterial Blood Pressure During Stimulation From Baseline(Test baseline (approximately minute 0) up to Test completion (approximately minute 60))
- Change in Subjective Arousal After Stimulation(Test baseline (approximately minute 0) up to Test completion (approximately minute 60))
研究者
Timothy Bruns
Associate Professor of Biomedical Engineering, Medical School
University of Michigan