Validation of a Multimodal Algorithm for Treatment of Fecal Incontinence in Women: Study of the Efficacy of the Combination of Treatments on the Impact on Clinical Severity and Quality of Life, and on the Underlying Pathophysiology
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Cleveland Severity Score
研究概览
简要总结
Thisi is a pragmatical clinical trial with the main aim of main aim of evaluating the effectiveness of the combination of treatments for the management of fecal incontinence (FI), on profiles of patients with IF based on pathophysiological criteria, measuring physiological, clinical and quality of life outputs.
Secondary:
- Evaluate the presence of SIBO, gluten-sensitive enteropathy, malabsorption of bile salts or sugars in patients with Bristol stools ≥5 that condition the fecal continuity.
- Effect of change in fecal consistency on IF symptoms.
- To evaluate the effect of the combination of treatments on anorectal physiology and neurophysiology (motor and sensory), clinical severity and quality of life.
- Evaluate the persistence of the treatments to the three months of end of the same.
详细描述
FI is a very prevalent condition in community dwelling women. We have previously studied the efectivenes of four treatments in women with FI as well as the effect on the anorectal physiology and neurophysiology. All treatments improved clinical symptoms of FI but there were no statistical differences between the treatments, that were Kegel exercises (K), biofeedback (BF)+K, electrostimulation (ES)+K, and transcutaneous neuromodulation (tNM)+K. With this prevoous study we have a clearer idea of the anorectal physiology which should allow to select patients for given treatments.
For the present study we try to validate a multimodal algorithm to treat FI, taking into account the underlying pahtophysiology.
It will have 2 differentiated stages:
Stage 1: Patients with loose stools (Bristol >5): they will be studied to determine the cause of the diahrrea (mainly food intolerances) and treated accordingly. If FI symptoms remain, patients will pass to:
Stage 2: Patients with Bristol<6 anf FI symptoms. They will be adressed to 3 combinations of treatments according to the pathophysiology that explain the symptoms, which will be:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 否
入选标准
- •FI episodes at least 6 months before
- •FI episodes each month
- •No other treatment the year before
- •Able to self-administer treatments
排除标准
- •Pregnancy
- •If, to investigators criteria, patient will fail to administer the tratmetns properly, due to physical or psychic conditions
结局指标
主要结局
Cleveland Severity Score
时间窗: 3 month and 6 month
Changes in clinical severity after the treatments measured with Cleveland score, which ranges from 0 (total continence) to 20 (very severe incontinence)
Anorectal physiology (motor)
时间窗: 3 month and 6 month
Changes in anal mean resting pressure and squeeze (voluntary) pressure after the treatments measured with mmHg
Quality of Life (QoL) according to FIQL scale
时间窗: 3 month and 6 month
Improvements in Fecal incontinence-related QoL after the treatments
Anorectal physiology (sensorial)
时间窗: 3 month and 6 month
Changes in rectal sensory thresholds after the treatments measured in volume (milliliters) of rectal distention
Anorectal neurophysiology
时间窗: 3 month and 6 month
Changes in pudendal nerve terminal motor latency (PNTML) measured with milliseconds
次要结局
未报告次要终点
研究者
Lluís Mundet
Motility Unit Coordinator
Hospital de Mataró