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

Fecal Incontinence Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03394794
• Other study ID #: IF02-11/2012
• Status: Completed
• Phase: N/A
• First received: November 29, 2017
• Last updated: January 8, 2018
• Start date: February 1, 2013
• Est. completion date: March 1, 2017

Study information

• Verified date: January 2018
• Source: Hospital de Mataró
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 1, 2017
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Mataró

Outcome

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