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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kegel exercises | Active Comparator | Pelvic floor exercises designed in the 1950s' by Arnold Kegel. |
|
| biofeedback | Experimental | Biofeeback therapy to improve neuromuscular coordination and strengthen sphincter contractility. |
|
| electrostimulation | Experimental | Administration of electric current with a specific device (stimulator) and through a vaginal prove, in order to improve pelvic floor contractility. |
|
| transcutaneous neuromodulation | Experimental | Stimulation of tibial nerve with a specific electric current through a stimulator and surface electrodes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic floor rehabilitation | Device | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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