NCT00387439

Brief Summary

The purpose of this study is to evaluate the impact of anoperineal physiotherapy in adjunction to standard medical treatment on symptoms and quality of life of adults with anal incontinence, in comparison with standard treatment alone. A total of 443 patients will be randomized to 2 groups: standard care (medical treatment) alone or standard care associated with anoperineal physiotherapy. Outcome measures include the patient own view of the effectiveness of the treatment, the continence score, quality of life and psychological status. These outcomes are measured at the end of the 4 months treatment period. Following this period, the non responders to standard medical treatment will be proposed to undergo a course of anoperineal physiotherapy and the non responders to anoperineal physiotherapy will be treated by transcutaneous electrical nerve stimulation (TENS). The outcomes will be measured at the end of the 4 months new treatment and again after 4 months follow-up.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
173

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

October 1, 2006

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2006

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

September 19, 2013

Status Verified

September 1, 2013

Enrollment Period

4.7 years

First QC Date

October 12, 2006

Last Update Submit

September 18, 2013

Conditions

Anal Incontinence

Keywords

Anal incontinenceGastroenterologyAnoperineal physiotherapyRandomized clinical trial

Outcome Measures

Primary Outcomes (1)

  • The primary outcome variable is the patient's response to the question "How would you grade your symptom": major aggravation; aggravation, no changes, improvement and major improvement and rating of that change on an ordinal scale of -5 to +5. The p

    during the treatment period

Secondary Outcomes (1)

  • Secondary outcomes include patient's symptoms questionnaire, continence score, quality of life questionnaire, stool diary and psychological status. These secondary outcomes are measured at the end of the 4 months treatment period and the end of follow-up

    at the end of the 4 months treatment period and the end of follow-up

Study Arms (2)

standard medical treatment

EXPERIMENTAL

standard medical treatment

Behavioral: Standard medical treatment

standard medical treatment + anoperineal physiotherapy

EXPERIMENTAL

standard medical treatment + anoperineal physiotherapy

Behavioral: standard medical treatment + anoperineal physiotherapy.

Interventions

standard medical treatment + anoperineal physiotherapy.BEHAVIORAL
standard medical treatment + anoperineal physiotherapy
Standard medical treatmentBEHAVIORAL
standard medical treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 75
  • Anal incontinence for more than six months.
  • Signed informed consent
  • Jorge and Wexner's anal incontinence score \> or egal 5

You may not qualify if:

  • Previous course of anoperineal physiotherapy within the past 6 months
  • Anorectal or perineal surgery within the past 6 months.
  • Indication for anoperineal surgery
  • Vaginal delivery within the past 6 months
  • Pregnancy
  • Major neurological disease,
  • Significant cognitive impairment, dementia or institutionalised.
  • Active inflammatory bowel disease.
  • Current treatment by sacral nerve neurostimulation.
  • Cardiac pacemaker
  • Skin damages preventing transcutaneous electrical nerve stimulation (TENS).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anne-Marie SCHOTT

Lyon, 69424, France

Location

MeSH Terms

Conditions

Encopresis

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorElimination DisordersMental Disorders

Study Officials

  • François MION, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2006

First Posted

October 13, 2006

Study Start

October 1, 2006

Primary Completion

June 1, 2011

Study Completion

December 1, 2011

Last Updated

September 19, 2013

Record last verified: 2013-09

Locations

FR(1)