Percutaneous Tibial Nerve Stimulation for Patients With Fecal Incontinence

Fecal Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01162525
• Other study ID #: pTNS
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: December 2017

Study information

• Verified date: September 2018
• Source: Cantonal Hospital of St. Gallen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

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).

Locations

Country	Name	City	State
Switzerland	Department of Surgery, Cantonal Hospital St. Gallen	St. Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Cantonal Hospital of St. Gallen

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fecal Incontinence	Jorge Wexner Score (Dis Colon Rectum (1993) 36:77) compared to pretreatment; Score for fecal incontinence, with 5 items and score range of 0 - 20	6 weeks
Primary	Fecal Incontinence	Jorge Wexner Score (Dis Colon Rectum (1993) 36:77) compared to pretreatment; Score for fecal incontinence, with 5 items and score range of 0 - 20	12 weeks
Primary	Fecal Incontinence	Jorge Wexner Score (Dis Colon Rectum (1993) 36:77) compared to pretreatment; Score for fecal incontinence, with 5 items and score range of 0 - 20	32 weeks
Secondary	Fecal Incontinence	Vaizey Score (Gut (1999) 44:77); Fecal incontinence score similar to Wexner Score	before treatment, 6, 12, 32 wks after initial treatment
Secondary	Anorectal manometric measurements	compared to pre-treatment values	12 weeks
Secondary	Quality of Life	2 scores for quality of life are measured: Fecal Incontinence Quality of Life (FIQL) (Dis Colon Rectum (2000) 43:9); Visual Analogue Score Patients are asked to score their well-being in respect to the incontinence by marking a horizontal 10 cm line labelled "extremely bad" and "excellent" at both ends	before treatment, 6, 32 wks after initial treatment
Secondary	Cost	total cost of treatment will be evaluated (material, work hours etc)	at the end of the treatment
Secondary	Adverse Events	adverse events between treatments: pain, bleeding, neurological sensation, other AE; Adverse events during percutaneous nerve stimulation: pain, bleeding and discomfort	for each treatment interval
Secondary	Urinary incontinence	Hanley Score (BMJ (2001) 322:1096); Urinary incontinence score	before treatment, 6, 12, 32 wks after initial treatment

External Links

•   Website of the Department of Surgery, Cantonal Hospital of St. Gallen (German only)