NCT03394794

Study of the Efficacy of 4 Treatments for Fecal Incontinence in Community-dwelling Women

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Hospital de Mataró · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2013-02-01
• Primary completion: 2016-12-01
• Completion: 2017-03-01
• First posted: 2018-01-09
• Last updated: 2018-01-09