Study of the Efficacy of 4 Treatments for Fecal Incontinence in Community-dwelling Women
- Conditions
- Fecal Incontinence
- Interventions
- Device: Pelvic floor rehabilitation
- Registration Number
- NCT03394794
- Lead Sponsor
- Hospital de Mataró
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 150
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Kegel exercises Pelvic floor rehabilitation Pelvic floor exercises designed in the 1950s' by Arnold Kegel. transcutaneous neuromodulation Pelvic floor rehabilitation Stimulation of tibial nerve with a specific electric current through a stimulator and surface electrodes electrostimulation Pelvic floor rehabilitation Administration of electric current with a specific device (stimulator) and through a vaginal prove, in order to improve pelvic floor contractility. biofeedback Pelvic floor rehabilitation Biofeeback therapy to improve neuromuscular coordination and strengthen sphincter contractility.
- Primary Outcome Measures
Name Time Method clinical severity Changes of severity after 3 month-treatment severity of the symptoms measured with Cleveland score
maximum anal resting pressure Changes maximum anal resting pressure after 3 month-treatment pressure of the anal canal measured with mmHg
maximum squeeze pressure Changes maximum squeeze pressure after 3 month-treatment pressure on the anal canal when squeezing measured with mmHg
rectal sensitivity changes in rectal balloon filling after 3 month-treatment patient's rectal perception, measured with cm3 of distention of a rectal balloon
- Secondary Outcome Measures
Name Time Method