Study of the Efficacy of 4 Treatments for Fecal Incontinence in Community-dwelling Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Fecal Incontinence

Intervention / Treatment
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* Device: Pelvic floor rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Kegel exercises<br>Pelvic floor exercises designed in the 1950s' by Arnold Kegel. | Device: Pelvic floor rehabilitation<br>* The aim is to compare how each treatment improves symptoms and quality of life and which physiologic mechanisms affects. The basal treatment which other therapies are compared to is Kegel.<br>|
| Experimental: biofeedback<br>Biofeeback therapy to improve neuromuscular coordination and strengthen sphincter contractility. | Device: Pelvic floor rehabilitation<br>* The aim is to compare how each treatment improves symptoms and quality of life and which physiologic mechanisms affects. The basal treatment which other therapies are compared to is Kegel.<br>|
| Experimental: electrostimulation<br>Administration of electric current with a specific device (stimulator) and through a vaginal prove, in order to improve pelvic floor contractility. | Device: Pelvic floor rehabilitation<br>* The aim is to compare how each treatment improves symptoms and quality of life and which physiologic mechanisms affects. The basal treatment which other therapies are compared to is Kegel.<br>|
| Experimental: transcutaneous neuromodulation<br>Stimulation of tibial nerve with a specific electric current through a stimulator and surface electrodes | Device: Pelvic floor rehabilitation<br>* The aim is to compare how each treatment improves symptoms and quality of life and which physiologic mechanisms affects. The basal treatment which other therapies are compared to is Kegel.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical severity | severity of the symptoms measured with Cleveland score | Changes of severity after 3 month-treatment | 
| maximum anal resting pressure | pressure of the anal canal measured with mmHg | Changes maximum anal resting pressure after 3 month-treatment | 
| maximum squeeze pressure | pressure on the anal canal when squeezing measured with mmHg | Changes maximum squeeze pressure after 3 month-treatment | 
| rectal sensitivity | patient's rectal perception, measured with cm3 of distention of a rectal balloon | changes in rectal balloon filling after 3 month-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anorectal physiology, therapies, quality fo life