Home Biofeedback or Pelvic Floor Physical Therapy for Postpartum Urinary Incontinence.: A Noninferiority Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 6
- 主要终点
- Determine the impact of both interventions on urinary incontinence-related quality of life using validated questionnaire
研究概览
简要总结
Pelvic floor dysfunction is commonly seen in the postpartum women with symptoms including urinary urgency and frequency, urinary incontinence and fecal incontinence. Pelvic floor physical therapy (PFPT) and home biofeedback devices have been shown to improve pelvic floor symptoms in postpartum and non-postpartum populations, respectively. This randomized noninferiority clinical trial will assess urinary incontinence-related quality of life in postpartum women with self-reported urinary incontinence who are randomized to a program of home biofeedback or pelvic floor physical therapy.
详细描述
The objective of this proposal is to determine if home biofeedback devices are noninferior to pelvic floor physical therapy for the treatment of postpartum urinary incontinence through a randomized noninferiority clinical trial. The hypothesis is that both interventions will improve incontinence-related quality of life and that home biofeedback will be noninferior to PFPT. Two specific aims will be investigated: 1) Determine the impact of both interventions on urinary incontinence-related quality of life measured by the change in score at 3-months on the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF); 2) Determine patient impression of symptoms improvement (measured by the change in score at 3-months and 1-year on the Patient Global Impression of Improvement scale or PGI-I), overall pelvic floor symptoms (measured by the change in score at 3-months and 1-year on the Pelvic Floor Distress Inventory of PFDI) and changes in sexual function (measured by a change in score at 3-months and 1-year in the Female Sexual Function Index or FSFI). An additional exploratory aim will be to observe the change in pelvic floor symptoms in the postpartum period at 3-months and 1-year among a cohort of women who elect for the standard of care without PFPT or biofeedback.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •following a vaginal delivery (primiparous or multiparous, spontaneous, forceps, or vacuum assisted)
- •willingness to participate in PFPT or home biofeedback exercises
- •access to a smartphone with Bluetooth capabilities
- •positive screen for urinary incontinence between 4 and 8 weeks postpartum defined as patient report of any urinary leakage within the prior two weeks
排除标准
- •multiple births or deliver at ≤34 weeks
- •previous urinary incontinence or pelvic organ prolapse surgery
- •self-identified pre-pregnancy pelvic floor disorder such as urinary incontinence
- •fecal incontinence or chronic pelvic pain or if they have a history of prior PFPT
结局指标
主要结局
Determine the impact of both interventions on urinary incontinence-related quality of life using validated questionnaire
时间窗: 3 months
Measured by the change in score on the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) between baseline and 3 months; scored between 0 and 21 with higher score meaning larger symptom burden
次要结局
- Determine the impact of both interventions on urinary incontinence-related quality of life using validated questionnaire(12 months)
- Determine the patient impression of symptom improvement using validated questionnaire(12 months)
- Determine overall pelvic floor symptoms measured by validated questionnaire(12 months)
- Determine changes in sexual function following intervention measured by validated questionnaire(12 months)
研究者
Jessica Sassani
Physician, Division of Urogynecology, Department of Obstetrics & Gynecology
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)