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Completed

NCT Number: NCT03394794

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. clinical severity

    Time frame: Changes of severity after 3 month-treatment

    severity of the symptoms measured with Cleveland score

  2. maximum anal resting pressure

    Time frame: Changes maximum anal resting pressure after 3 month-treatment

    pressure of the anal canal measured with mmHg

  3. maximum squeeze pressure

    Time frame: Changes maximum squeeze pressure after 3 month-treatment

    pressure on the anal canal when squeezing measured with mmHg

  4. rectal sensitivity

    Time frame: changes in rectal balloon filling after 3 month-treatment

    patient's rectal perception, measured with cm3 of distention of a rectal balloon

Sponsors and collaborators

Lead sponsor

Hospital de Mataró

Other

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Jan 9, 2018
Registry last updated
Jan 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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