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

Sponsor
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (Other)
Overall Status
Completed
CT.gov ID
NCT05016453
Collaborator
(none)
139
Enrollment
1
Location
135.5
Actual Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    139 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Long-term Efficacy of Percutaneous Tibial Nerve Stimulation for Faecal Incontinence and New Approach for Partial Responders
    Actual Study Start Date :
    Jan 8, 2010
    Actual Primary Completion Date :
    Jun 15, 2017
    Actual Study Completion Date :
    Apr 24, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Change in faecal incontinence assessed by Wexner Score [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).

    Secondary Outcome Measures

    1. Predictors of good long-term improvement in Wexner score [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

    2. Partial Responders [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital General Universitario de Elche Elche Alicante Spain 03203

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Luis Sánchez Guillen, Clinical Professor Luis Sánchez-Guillén, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
    ClinicalTrials.gov Identifier:
    NCT05016453
    Other Study ID Numbers:
    • PTNSLONGTERMEFFICACY
    First Posted:
    Aug 23, 2021
    Last Update Posted:
    Aug 23, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Luis Sánchez Guillen, Clinical Professor Luis Sánchez-Guillén, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
    percutaneous tibial nerve stimulation
    anal physiology
    faecal incontinence
    partial response
    long-term efficacy
    Additional relevant MeSH terms:
    Fecal Incontinence

    Study Results

    No Results Posted as of Aug 23, 2021