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

Hospital de Mataró

Status: Completed

Conditions: Fecal Incontinence

Treatments: Device: Pelvic floor rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT03394794

IF02-11/2012

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 4 patient groups

Kegel exercises

Active Comparator group

Description:

Pelvic floor exercises designed in the 1950s' by Arnold Kegel.

Treatment:

Device: Pelvic floor rehabilitation

biofeedback

Experimental group

Description:

Biofeeback therapy to improve neuromuscular coordination and strengthen sphincter contractility.

Treatment:

Device: Pelvic floor rehabilitation

electrostimulation

Experimental group

Description:

Administration of electric current with a specific device (stimulator) and through a vaginal prove, in order to improve pelvic floor contractility.

Treatment:

Device: Pelvic floor rehabilitation

transcutaneous neuromodulation

Experimental group

Description:

Stimulation of tibial nerve with a specific electric current through a stimulator and surface electrodes

Treatment:

Device: Pelvic floor rehabilitation