Clinical trial NCT03394794: 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
Overall status: COMPLETED
Phase: NA
Conditions: Fecal Incontinence
Keywords: anorectal physiology
therapies
quality fo life
Lead sponsor: Hospital de Mataró
Sponsor class: OTHER
First posted: 2018-01-09
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: clinical severity
timeFrame: Changes of severity after 3 month-treatment
measure: maximum anal resting pressure
timeFrame: Changes maximum anal resting pressure after 3 month-treatment
measure: maximum squeeze pressure
timeFrame: Changes maximum squeeze pressure after 3 month-treatment
measure: rectal sensitivity
timeFrame: changes in rectal balloon filling after 3 month-treatment
Secondary outcomes:
Other outcomes:
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Study officials:
References: