DRKS00027319已完成未知
Prospective, multicenter, randomized, controlled, single-blind other clinical trial. What is the efficacy of pelvic floor biofeedback training with ACTICORE1® for stress incontinence? - ACU-II-trial
ACTICORE GmbH0 个研究点目标入组 124 人开始时间: 2022年1月19日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 124
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 99 Years（—）
- 性别
- Female
入选标准
- •Stress incontinence with subjective impairment and an ICIQ score of greater 6
- •- Women who can contract their BB at will with an Oxford grading standing of
- •of at least 2.
- •- Women and men over the age of 65 are also included as vulnerable individuals.
- •Availability of a smartphone/tablet, ability to operate same e.g. download app,
- •Pairing smartphone sensor
- •- Internet access available on a daily basis
- •- Creation of a user profile in the ACTICORE1 app.
排除标准
- •- Patient refusal to participate in the study
- •- Pregnancy
- •- Inability to understand the content and scope of the study
- •- vulvodynia
- •- Paraplegic symptoms due to traumatic injuries to the nerves and spinal cord at the
- •cervical, thoracic, lumbar and sacral levels.
- •- Congenital paraplegia symptomatology
- •- Patients with sacral, perianal open secretory wounds following rectal and rectal resection and amputation.
- •rectal resection and amputations
- •- ICQ score less than 5
- •- ASA score IV and V
- •- Oxford grading 0 and 1 (standing) (principle contractility of the pelvic floor for the
- •ACTICORE use required)
研究者
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