Study of the Efficacy of 4 Treatments for Fecal Incontinence in Community-dwelling Women
NCT ID: NCT03394794
Last Updated: 2018-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2013-02-01
2017-03-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Kegel exercises
Pelvic floor exercises designed in the 1950s' by Arnold Kegel.
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.
biofeedback
Biofeeback therapy to improve neuromuscular coordination and strengthen sphincter contractility.
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.
electrostimulation
Administration of electric current with a specific device (stimulator) and through a vaginal prove, in order to improve pelvic floor contractility.
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.
transcutaneous neuromodulation
Stimulation of tibial nerve with a specific electric current through a stimulator and surface electrodes
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
18 Years
FEMALE
Yes
Sponsors
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Hospital de Mataró
OTHER
Responsible Party
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Lluís Mundet
GI motility clinician / researcher
Other Identifiers
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IF02-11/2012
Identifier Type: -
Identifier Source: org_study_id
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