NCT01162525

Percutaneous Tibial Nerve Stimulation for Patients With Fecal Incontinence

Percutaneous Tibial Nerve Stimulation (pTNS) for Patients With Fecal Urge Incontinence

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Cantonal Hospital of St. Gallen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
PROCEDURE	Percutaneous tibial nerve stimulation (pTNS)	A 34 gauge needle in placed close to the tibial nerve about 2-3 cm above the ankle. A self-adhesive surface electrode is placed on the skin. Needle and surface electrode are connected to an electric stimulator and the stimulating current (0 - 10 mA) is increased in 20 steps. When the patient feels a tingling sensation in the foot, stimulating current is set back for one step and the treatment is started (30 min stimulation).

Timeline

• Start date: 2010-01-01
• Primary completion: 2017-10-01
• Completion: 2017-12-01
• First posted: 2010-07-14
• Last updated: 2018-09-19

Locations

1 site across 1 country: Switzerland