DRKS00033971尚未招募Unknown
Prospective, multicenter, randomized, controlled, single-blind other clinical trial. What is the efficacy of app-based biofeedback training with ACTICORE1® for female stress incontinence? - ACU-3-trial
ACTICORE GmbH0 个研究点目标入组 262 人开始时间: 2024年4月4日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 262
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
- •* Patients with non-binary gender identity with stress incontinence
- •* Age: 18 years
- •* ICIQ-UI SF Score > 5:
- •* Frequency of urinary incontinence episodes per day (average)
- •* Women who are able to calibrate the ACTICORE1 SensorSeat by contracting their pelvic floor as specified (lifting) by the ACTICORE1 app
- •* Smartphone/tablet for using the ACTICORE1 app with sufficient hardware and software compatibility available
- •* Ability to use the ACTICORE1 app, e.g. downloading the app, Bluetooth pairing of the ACTICORE1 app and ACTICORE1 SensorSeat
- •* Valid private electronic address
- •* Internet access available daily
- •* Willingness to create a user profile in the ACTICORE1 app
- •* Resident in Germany
- •* Ability to use the German To read and understand language
- •* Treatment request
排除标准
- •* newly started drug therapy for urinary incontinence
- •* implementation of pelvic floor therapy
- •* any previous use of the ACTICORE1® intervention
- •* use of another app for pelvic floor training
- •* inability to understand the content and extent of the study
- •* cognitive deficits or psychiatric illnesses
- •* dementia
- •* refusal of participation in the study by the patient
- •* pregnancy
- •* participation in another clinical study to improve continence
- •* employees of ACTICORE AG / ACTICORE GmbH or another institution involved in the implementation/organization/coordination/financing of the study
- •* previous operations in the area of ??the sphincter (levator ani muscle)
- •* expected/scheduled pelvic surgical interventions (including laser therapy),
- •* patients after surgical interventions and/or laser therapy to improve continence
- •* vulvodynia
- •* paraplegia due to traumatic injuries to the nerves and spinal cord in cervical, thoracic, lumbar and sacral level
- •* congenital paraplegia
- •* ASA score IV and V
- •* organ prolapse
- •* hormone therapy or gender reassignment
- •* permanent bladder catheter
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