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

Hospital de Mataró150 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Fecal Incontinence

Interventions

Pelvic floor rehabilitationDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

clinical severity

severity of the symptoms measured with Cleveland score

Time frame: Changes of severity after 3 month-treatment

maximum anal resting pressure

pressure of the anal canal measured with mmHg

Time frame: Changes maximum anal resting pressure after 3 month-treatment

maximum squeeze pressure

pressure on the anal canal when squeezing measured with mmHg

Time frame: Changes maximum squeeze pressure after 3 month-treatment

rectal sensitivity

patient's rectal perception, measured with cm3 of distention of a rectal balloon

Time frame: changes in rectal balloon filling after 3 month-treatment

Data from ClinicalTrials.gov

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