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

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

Status

Completed

Conditions

Faecal Incontinence

Study type

Observational

Funder types

Other

Identifiers

NCT05016453
PTNSLONGTERMEFFICACY

Details and patient eligibility

About

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.

Full 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.

Enrollment

139 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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