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

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.

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.

Study Overview

• Status: Completed
• Conditions: Fecal Incontinence
• Intervention / Treatment: Device: Pelvic floor rehabilitation

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Kegel exercises; Pelvic floor exercises designed in the 1950s' by Arnold Kegel.	Device: Pelvic floor rehabilitation; 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.
Experimental: biofeedback; Biofeeback therapy to improve neuromuscular coordination and strengthen sphincter contractility.	Device: Pelvic floor rehabilitation; 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.
Experimental: electrostimulation; 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; 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.
Experimental: transcutaneous neuromodulation; Stimulation of tibial nerve with a specific electric current through a stimulator and surface electrodes	Device: Pelvic floor rehabilitation; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital de Mataró

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: November 29, 2017
• First Submitted That Met QC Criteria: January 8, 2018
• First Posted (Actual): January 9, 2018

Study Record Updates

• Last Update Posted (Actual): January 9, 2018
• Last Update Submitted That Met QC Criteria: January 8, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: anorectal physiology; therapies; quality fo life
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: IF02-11/2012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No