Validation of a Multimodal Algorithm for the Treatment of Fecal Incontinence

Study Overview
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Brief Summary
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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.

Detailed Description
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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: BF+ES+K: those patients with direct sphincter damage BF+tNM+K: patients with external anal sphincter dennervation and/or colonic motility disorders. BF alones: patients with FI mainly explained by a bad control of the pelvic floor function (akinesia/dyssynergia). All patients will be studied with High Resolution Anorectal Manometry, PNTML, endoanal unltrasonography. Clinical severity and QoL with dedicated intruments or questionnaires. If after 1sr stage, if so, patients have a clinical severity of Cleveland<4 they will be followed up at 3 months with K, studued again their clinical severity and QoL. After 2nd stage, if so, 3-month of targeted treatment will be performed, and reevaluated with HRAM, PNTML and clinical questionnaires. They will be followed up at 3 monts with only K to study the persistance of the treatments.

Official Title
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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

Conditions
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Fecal Incontinence

Intervention / Treatment
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* Combination Product: Biofeedback+Electrostimulation+Kegel
* Device: Biofeedback+Tibial Neuromodulation+Kegel
* Combination Product: Biofeedback+Kegel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: FI episodes at least 6 months before FI episodes each month No other treatment the year before Able to self-administer treatments Exclusion Criteria: Pregnancy If, to investigators criteria, patient will fail to administer the tratmetns properly, due to physical or psychic conditions

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Biofeedback+Electrostimulation+Kegel<br>Biofeedback (3 sessions) Electrostimulation (12 weeks daily treatment) Kegel exercises (twice daily) | Device: Biofeedback+Tibial Neuromodulation+Kegel<br>* Biofeedback (3 sessions) Transcutaneous Neuromodulation (12 weeks daily treatment) Kegel exercises (twice daily)<br>* Other names: BF+tNM+K;Combination Product: Biofeedback+Kegel<br>* Biofeedback+Kegel exercises<br>* Other names: BF+K;|
| Active Comparator: Biofeedback+Tibial Neuromodulation+Kegel<br>Biofeedback (3 sessions) Transcutaneous Neuromodulation (12 weeks daily treatment) Kegel exercises (twice daily) | Combination Product: Biofeedback+Electrostimulation+Kegel<br>* Biofeedback (3 sessions) Electrostimulation (12 weeks daily treatment) Kegel exercises (twice daily)<br>* Other names: BF+ES+K;Combination Product: Biofeedback+Kegel<br>* Biofeedback+Kegel exercises<br>* Other names: BF+K;|
| Active Comparator: Biofeedback+Kegel<br>Biofeedback (6 sessions) Kegel exercises (twice daily) | Combination Product: Biofeedback+Electrostimulation+Kegel<br>* Biofeedback (3 sessions) Electrostimulation (12 weeks daily treatment) Kegel exercises (twice daily)<br>* Other names: BF+ES+K;Device: Biofeedback+Tibial Neuromodulation+Kegel<br>* Biofeedback (3 sessions) Transcutaneous Neuromodulation (12 weeks daily treatment) Kegel exercises (twice daily)<br>* Other names: BF+tNM+K;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cleveland Severity Score | Changes in clinical severity after the treatments measured with Cleveland score, which ranges from 0 (total continence) to 20 (very severe incontinence) | 3 month and 6 month | 
| Anorectal physiology (motor) | Changes in anal mean resting pressure and squeeze (voluntary) pressure after the treatments measured with mmHg | 3 month and 6 month | 
| Anorectal physiology (sensorial) | Changes in rectal sensory thresholds after the treatments measured in volume (milliliters) of rectal distention | 3 month and 6 month | 
| Anorectal neurophysiology | Changes in pudendal nerve terminal motor latency (PNTML) measured with milliseconds | 3 month and 6 month | 
| Quality of Life (QoL) according to FIQL scale | Improvements in Fecal incontinence-related QoL after the treatments | 3 month and 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fecal incontinence, anorectal physiology, pragmatic clinical trial