Skip to main content
OpenTrials
Completed

NCT Number: NCT05016453

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Faecal Incontinence Behavior Behavioral Symptoms Elimination Disorders Encopresis Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: PTNSLONG

Important dates

Study start
2010
Primary completion
2017
Study completion
2021
First posted
Aug 23, 2021
Registry last updated
Aug 23, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.