Percutaneous Tibial Nerve Stimulation (pTNS) for Patients With Fecal Urge Incontinence
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fecal Incontinence
- Sponsor
- Cantonal Hospital of St. Gallen
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- Fecal Incontinence
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
Lukas Marti
Attending physician
Cantonal Hospital of St. Gallen
Eligibility Criteria
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
Outcomes
Primary Outcomes
Fecal Incontinence
Time Frame: 32 weeks
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
Secondary Outcomes
- Adverse Events(for each treatment interval)
- Urinary incontinence(before treatment, 6, 12, 32 wks after initial treatment)
- Cost(at the end of the treatment)
- Fecal Incontinence(before treatment, 6, 12, 32 wks after initial treatment)
- Anorectal manometric measurements(12 weeks)
- Quality of Life(before treatment, 6, 32 wks after initial treatment)