Percutaneous Tibial Nerve Stimulation for Patients With Fecal Incontinence

Cantonal Hospital of St. Gallen

Status: Completed

Conditions: Fecal Incontinence

Treatments: Procedure: Percutaneous tibial nerve stimulation (pTNS)

Study type: Interventional

Funder types: Other

Identifiers

NCT01162525

pTNS

Details and patient eligibility

About

Percutaneous tibial nerve stimulation is introduced as regular treatment option for fecal urge continence at the Cantonal Hospital St. Gallen. During this introduction phase efficiency und adverse events will be monitored in this observational study.

Full description

Before treatment patients will have a proctological exam, a proctoscopy, endosonography and anorectal manometry. Incontinence scores (Wexner, Vaizey, Hanley) and quality of life scores (FIQL, VAS) will be recorded.

Treatment consists of 4 phases with decreasing frequency of percutaneous tibial nerve stimulations (pTNS).

During phase 1 weekly stimulations of 30 mins are applied for 12 weeks. After 6 and 12 weeks incontinence scores are recorded. Additionally after the end of phase 1 quality of life is measured and an anorectal manometry is preformed.

Phase 2 lasts for 8 weeks, with 2-3 stimulations/month Phase 3 lasts for 8 weeks, with stimulations every 3 weeks Phase 4 consists of one stimulation in one month.

After phase 4 incontinence scores und quality of life are measured.

Enrollment: 57 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• fecal urge incontinence
• conservative treatment has been performed without success

Exclusion criteria

• current anticoagulation treatment
• sphincter defects larger than 120°
• pregnancy
• pace maker
• implanted defibrillators
• severe heart disease
• existing neurological damages
• disposition for strong bleeding

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 1 patient group

pTNS treatment

Experimental group

Treatment:

Procedure: Percutaneous tibial nerve stimulation (pTNS)