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

NCT05016453 | Completed DMC

• 1 other identifier: PTNSLONGTERMEFFICACY
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Faecal Incontinence

Keywords

percutaneous tibial nerve stimulation; anal physiology; faecal incontinence; partial response; long-term efficacy

Outcome Measures

Primary Outcomes (1)

• Change in faecal incontinence assessed by Wexner Score

  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 Outcomes (2)

• Predictors of good long-term improvement in Wexner score

  At 3, 6 and 12 months after start of PTNS

• Partial Responders

  At 3, 6 and12 months after start of PTNS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

Location

Related Publications (24)

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• Hotouras A, Thaha MA, Allison ME, Currie A, Scott SM, Chan CL. Percutaneous tibial nerve stimulation (PTNS) in females with faecal incontinence: the impact of sphincter morphology and rectal sensation on the clinical outcome. Int J Colorectal Dis. 2012 Jul;27(7):927-30. doi: 10.1007/s00384-011-1405-3. Epub 2012 Jan 25.

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MeSH Terms

Conditions

Encopresis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor Luis Sánchez-Guillén

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: August 23, 2021
• Study Start: January 8, 2010
• Primary Completion: June 15, 2017
• Study Completion: April 24, 2021
• Last Updated: August 23, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)