Vaginal Electrical Stimulation for Postpartum Neuromuscular Recovery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Anal Incontinence
研究概览
简要总结
For too many women, childbirth results in devastating consequences: involuntary loss of feces or urine (fecal or urinary incontinence). In fact, up to 50 percent of women with severe tears during childbirth may develop these problems. These new mothers avoid leaving home in order to stay close to a toilet, wear protective pads every day, and avoid activities they previously enjoyed such as exercise and sexual intercourse. It is not surprising that many of these women suffer from postpartum depression, and bonding with their newborns is compromised.
Fecal and urinary incontinence occur due to injuries to the pelvic nerves and muscles during childbirth. Many researchers have focused on what can be done to prevent these injuries; however, few have investigated how to help the countless women who have already suffered from these injuries to the nerves and muscles. In other fields such as orthopedics and neurology, research shows that electrical stimulation can provoke nerve regeneration after injury. Applying this technology to women who have recently suffered from nerve injury during childbirth could have profound and life-changing effects. Investigators hypothesize that electrical stimulation immediately postpartum will markedly help pelvic nerves regenerate, minimizing rates of fecal and urinary incontinence for this vulnerable population of new mothers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primiparous (First delivery)
- •Women who sustain Obstetric Anal Sphincter Injury (OASIS) during first vaginal delivery
- •Between age of 18 - 50 years
- •English speaking and reading
排除标准
- •Implanted electrical device or cardiac arrhythmia
- •Neurological disorder
- •Inflammatory bowel disease
- •Chronic Steroid Use
- •Wound breakdown and infection
- •Anticipated geographic relocation
结局指标
主要结局
Anal Incontinence
时间窗: 13 weeks postpartum
The FISI is a validated instrument for assessing fecal incontinence symptom severity. The questionnaire contains 4 questions that assess the frequency of incontinence of solid stool, liquid stool, mucus and gas. FISI total scores range from 0-61 points and higher scores on the scale indicate greater severity of anal incontinence symptoms (worse symptoms). The following are ranges of the scores for each subscale, similarly higher scores on the scale indicate greater severity of subtype of anal incontinence (worse symptoms) Gas subscale- 0-12 points Mucus subscale: 0- 12 points Liquid stool subscale: 0-19 points Solid stool subscale: 0-18 points There are units for the scores on the scale. The Total FISI score is derived from the sum of all the scores on the subscales.
次要结局
- Number of Patients With Anal Sphincter Muscle Defects(13 weeks postpartum)
- Urinary Incontinence(1 week postpartum and 13 weeks postpartum)
- Number of Participants With Levator Ani Muscle Defects on Either Side of the Pelvis(13 weeks postpartum)
- Maximum Squeeze Anal Pressure(13 weeks postpartum)
研究者
Christina Lewicky-Gaupp
Assistant Professor, Department of Obstetrics & Gynecology
Northwestern University
