Feasibility of Pelvic Floor Muscle Training With a Digital Therapeutic Motion-based Device (Leva Device) in a Postpartum Population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Feasibility
研究概览
简要总结
The goal of this prospective cohort study is to evaluate the feasibility of postpartum pelvic floor muscle training using an FDA-cleared digital therapeutic motion-based device.
In addition to assessing feasibility, investigators also will evaluate bladder and bowel function, pelvic organ prolapse symptoms, and vaginal and perineal pain in the immediate postpartum period and at 3 and 6 months postpartum. Investigators also will assess sexual function at 3 and 6 months postpartum.
Participants will use the motion-based device for postpartum pelvic floor muscle training and will complete electronically administered surveys at 3 and 6 months postpartum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- 否
入选标准
- •Spontaneous vaginal delivery within the last 4-8 weeks
- •Age ≥ 18 years
- •Ambulatory
- •Willing and able to consent to participate.
- •English speaking
- •Owns a smartphone
排除标准
- •Operative or cesarean delivery
- •Obstetric delivery at less than 20 weeks gestation
- •Third- or fourth-degree perineal laceration
- •Episiotomy
- •Multiples
结局指标
主要结局
Feasibility
时间窗: From enrollment to 6 months postpartum
Feasibility will be assessed using participant reported discomfort with device use, ease of device use, net promotor score, patient satisfaction, and free text feedback on the device.
Perineal Pain
时间窗: From enrollment to 6 months postpartum
Participants will complete validated surveys assessing perineal pain at baseline, 3 months postpartum, and 6 months postpartum.
次要结局
- Bladder function(From enrollment to 6 months postpartum)
- Bowel Function(From enrollment to 6 months postpartum)
- Pelvic Organ Prolapse(From enrollment to 6 months postpartum)
- Vaginal pain(From enrollment to 6 months postpartum)
- Sexual function(From enrollment to 6 months postpartum)