Study of the Efficacy of 4 Treatments for Fecal Incontinence in Community-dwelling Women
Primary Purpose
Fecal Incontinence
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pelvic floor rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Fecal Incontinence focused on measuring anorectal physiology, therapies, quality fo life
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
Kegel exercises
biofeedback
electrostimulation
transcutaneous neuromodulation
Arm Description
Pelvic floor exercises designed in the 1950s' by Arnold Kegel.
Biofeeback therapy to improve neuromuscular coordination and strengthen sphincter contractility.
Administration of electric current with a specific device (stimulator) and through a vaginal prove, in order to improve pelvic floor contractility.
Stimulation of tibial nerve with a specific electric current through a stimulator and surface electrodes
Outcomes
Primary Outcome Measures
clinical severity
severity of the symptoms measured with Cleveland score
maximum anal resting pressure
pressure of the anal canal measured with mmHg
maximum squeeze pressure
pressure on the anal canal when squeezing measured with mmHg
rectal sensitivity
patient's rectal perception, measured with cm3 of distention of a rectal balloon
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03394794
Brief Title
Study of the Efficacy of 4 Treatments for Fecal Incontinence in Community-dwelling Women
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2013 (Actual)
Primary Completion Date
December 1, 2016 (Actual)
Study Completion Date
March 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Mataró
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence
Keywords
anorectal physiology, therapies, quality fo life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Kegel exercises
Arm Type
Active Comparator
Arm Description
Pelvic floor exercises designed in the 1950s' by Arnold Kegel.
Arm Title
biofeedback
Arm Type
Experimental
Arm Description
Biofeeback therapy to improve neuromuscular coordination and strengthen sphincter contractility.
Arm Title
electrostimulation
Arm Type
Experimental
Arm Description
Administration of electric current with a specific device (stimulator) and through a vaginal prove, in order to improve pelvic floor contractility.
Arm Title
transcutaneous neuromodulation
Arm Type
Experimental
Arm Description
Stimulation of tibial nerve with a specific electric current through a stimulator and surface electrodes
Intervention Type
Device
Intervention Name(s)
Pelvic floor rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
clinical severity
Description
severity of the symptoms measured with Cleveland score
Time Frame
Changes of severity after 3 month-treatment
Title
maximum anal resting pressure
Description
pressure of the anal canal measured with mmHg
Time Frame
Changes maximum anal resting pressure after 3 month-treatment
Title
maximum squeeze pressure
Description
pressure on the anal canal when squeezing measured with mmHg
Time Frame
Changes maximum squeeze pressure after 3 month-treatment
Title
rectal sensitivity
Description
patient's rectal perception, measured with cm3 of distention of a rectal balloon
Time Frame
changes in rectal balloon filling after 3 month-treatment
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of the Efficacy of 4 Treatments for Fecal Incontinence in Community-dwelling Women
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