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.
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.
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.
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