Study of the Efficacy of Treatment of Fecal Incontinence in Community-dwelling Women: Assessment of Individual Efficacy on Anorectal Physiology and Cortical Plasticity, Its Impact on Clinical Severity and on Quality of Life.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 主要终点
- clinical severity
研究概览
简要总结
This is a RCT aimed to assessing efficacy of kegel exercises,biofeedback, electrostimulation and transcutaneous neuromodulation on women with fecal incontinence, measuring its impact on anorectal physiology, cortical plasticity, clmical severity and the quality of life.
详细描述
Fecal incontinence is a prevalent condition with a major impact on quality of life. Currently four treatments are being used in clinical practice: Kegel exercises (K), biofeedback (BF), electrostimulation (ES) and transcutaneous neuromodulation (NM). Results in the literature are discordant and lack methodological rigour making scientific evidence weak.
The aim of this study is to assess the efficacy of these four treatments on community-dwelling women and their impact on anorectal physiology, on clinical severity and on QoL.
This is a randomized control trial. Patient physiology was studied with anorectal manometry and endoanal ultrasonography; clinical severity was assessed with Cleveland and St. Mark's scales, and QoL with the Faecal Incontinence Quality of Life (FIQL) and the EuroQol's EQ5D questionnaires. Urinary incontinence (UI) was also evaluated by means of International Consultation on Incontinence (ICIQ) score. Patients were randomized and assigned to K (control), BF+K, ES+K or NM+K, given active treatment for a 3-month period, and then evaluated again with identical tests and parameters to identify changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Age higher than 18
- •To be woman
- •Have had incontinence episiodes at least from 6 month since the beginning of the study
- •Have had incontinence episodes during the last month prior the beginning of the study
- •The patient is able to understand the nature and impliations of the study and, therefore, to decide her participation.
排除标准
- •Not meeting inclusion criteria
- •Have very mild condition (Wexner <4)
- •To be unable to perform / understand the treatments properly
- •Being pregnant
- •To have used treatmets for fecal incontinence within the last six months prior to the start of the study
- •If, at reserarcher's criteria, the patient has not the proper conditions to perform and finish the treatments.
研究组 & 干预措施
Kegel exercises
Pelvic floor exercises designed in the 1950s' by Arnold Kegel.
干预措施: Pelvic floor rehabilitation (Device)
biofeedback
Biofeeback therapy to improve neuromuscular coordination and strengthen sphincter contractility.
干预措施: Pelvic floor rehabilitation (Device)
electrostimulation
Administration of electric current with a specific device (stimulator) and through a vaginal prove, in order to improve pelvic floor contractility.
干预措施: Pelvic floor rehabilitation (Device)
transcutaneous neuromodulation
Stimulation of tibial nerve with a specific electric current through a stimulator and surface electrodes
干预措施: Pelvic floor rehabilitation (Device)
结局指标
主要结局
clinical severity
时间窗: Changes of severity after 3 month-treatment
severity of the symptoms measured with Cleveland score
maximum anal resting pressure
时间窗: Changes maximum anal resting pressure after 3 month-treatment
pressure of the anal canal measured with mmHg
maximum squeeze pressure
时间窗: Changes maximum squeeze pressure after 3 month-treatment
pressure on the anal canal when squeezing measured with mmHg
rectal sensitivity
时间窗: changes in rectal balloon filling after 3 month-treatment
patient's rectal perception, measured with cm3 of distention of a rectal balloon
次要结局
未报告次要终点
研究者
Lluís Mundet
GI motility clinician / researcher
Hospital de Mataró