NCT03394794

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 9, 2018

Completed
Last Updated

January 9, 2018

Status Verified

January 1, 2018

Enrollment Period

3.8 years

First QC Date

November 29, 2017

Last Update Submit

January 8, 2018

Conditions

Fecal Incontinence

Keywords

anorectal physiologytherapiesquality fo life

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (4)

Kegel exercises

ACTIVE COMPARATOR

Pelvic floor exercises designed in the 1950s' by Arnold Kegel.

Device: Pelvic floor rehabilitation

biofeedback

EXPERIMENTAL

Biofeeback therapy to improve neuromuscular coordination and strengthen sphincter contractility.

Device: Pelvic floor rehabilitation

electrostimulation

EXPERIMENTAL

Administration of electric current with a specific device (stimulator) and through a vaginal prove, in order to improve pelvic floor contractility.

Device: Pelvic floor rehabilitation

transcutaneous neuromodulation

EXPERIMENTAL

Stimulation of tibial nerve with a specific electric current through a stimulator and surface electrodes

Device: Pelvic floor rehabilitation

Interventions

Pelvic floor rehabilitationDEVICE

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.

Kegel exercisesbiofeedbackelectrostimulationtranscutaneous neuromodulation

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
GI motility clinician / researcher

Study Record Dates

First Submitted

November 29, 2017

First Posted

January 9, 2018

Study Start

February 1, 2013

Primary Completion

December 1, 2016

Study Completion

March 1, 2017

Last Updated

January 9, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share