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临床试验/NCT02701413
NCT02701413已完成不适用

Vaginal Electrical Stimulation for Postpartum Neuromuscular Recovery

Northwestern University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2016年2月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
1
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

研究组 & 干预措施

ApexM Device

Experimental

The ApexM Device (InControl Medical) is a cylindrical inflatable instrument with electrodes on the dorsal and ventral sides. It is a battery operated, non-implanted device which will be inserted into the vagina and will stimulate the pelvic floor muscles. This device has been shown to be safe and effective for clinical use. Stimulation will alternate between 13 and 50Hz. The initial intensity will be set by the clinician at the patient's initial visit and will be increased in a standard fashion over the duration of the trial.

干预措施: ApexM (Stimulation) Device (Device)

Sham Device

Sham Comparator

The ApexM Device will be identical in every way but the electrical stimulation will be disabled. The device will still turn on and inflate to fit the contours of the vagina.

干预措施: Sham Device (Device)

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christina Lewicky-Gaupp

Assistant Professor, Department of Obstetrics & Gynecology

Northwestern University

研究点 (1)

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