Long-term Efficacy of Percutaneous Tibial Nerve Stimulation Applied to Patients With Faecal Incontinence. (PTNSLONG)

August 16, 2021 updated by: Luis Sánchez Guillen, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Long-term Efficacy of Percutaneous Tibial Nerve Stimulation for Faecal Incontinence and New Approach for Partial Responders

Percutaneous tibial nerve stimulation (PTNS) is an ambulatory therapy validated for patients with Faecal Incontinence (FI) refractory to conservative treatment with proved short and mid-term efficacy.

The investigators therefore aimed to evaluate the long-term efficacy of PTNS, considered 3 years of follow-up. The investigators also aimed to identify predictors of responses and suggest a new approach for partial responders.

Study Overview

Status

Completed

Conditions

Detailed Description

Prospective single-centre cohort of patients with FI treated with PTNS was analysed.

PTNS sessions were performed in three phases: weekly for three months in the first phase, biweekly for three months in the second phase, and monthly for six months in the third and final phase.

Clinical control at the end of each phase and an additional follow-up was performed at 36 months. Wexner score, faecal urgency, bowel habits and quality of life for FI were assessed.

Patients were categorized in three groups: optimal responders when there was an improvement in Wexner score > 50%; partial responders if the improvement in Wexner score was 25-50%; and non-responders, when the improvement of Wexner score was < 25%.

Optimal responders and partial responders progressed into successive phases, whereas non-responders abandoned PTNS and other treatment options were offered.

Study Type

Observational

Enrollment (Actual)

139

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Hospital General Universitario de Elche

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients older than 18 years old, diagnosed with faecal incontinence (at least one or more episodes of faecal incontinence for more than 6 months) refractory to conservative treatment.

Description

Inclusion Criteria:

  • Diagnosis of faecal incontinence for more than 6 months, refractory to conservative treatment.

Exclusion Criteria:

  • Anatomic injuries that require surgery.
  • External anal sphincter lesion of > 180º.
  • Unavailability to attend regularly outpatient clinic.
  • Major psychologic or psychiatric comorbidities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in faecal incontinence assessed by Wexner Score
Time Frame: Baseline compared to 3, 6, 12 and 36 months after start of PTNS
Rate of patients with improvement in faecal incontinence assessed by Wexner score (Maximum punctuation: 20 being severe incontinence. Minimum punctuation: 0, no incontinence).
Baseline compared to 3, 6, 12 and 36 months after start of PTNS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictors of good long-term improvement in Wexner score
Time Frame: At 3, 6 and 12 months after start of PTNS
Influence of previous obstetric or surgery history and duration of symptoms in the variation of Wexner score
At 3, 6 and 12 months after start of PTNS
Partial Responders
Time Frame: At 3, 6 and12 months after start of PTNS
Incidence of patients with a decrease in Wexner score between 25 and 50% compared to initial value, and their performance in the long term
At 3, 6 and12 months after start of PTNS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 8, 2010

Primary Completion (ACTUAL)

June 15, 2017

Study Completion (ACTUAL)

April 24, 2021

Study Registration Dates

First Submitted

July 6, 2021

First Submitted That Met QC Criteria

August 16, 2021

First Posted (ACTUAL)

August 23, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 23, 2021

Last Update Submitted That Met QC Criteria

August 16, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTNSLONGTERMEFFICACY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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