Percutaneous Tibial Nerve Stimulation for Patients With Fecal Incontinence
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Fecal Incontinence |
Procedure: Percutaneous tibial nerve stimulation (pTNS) |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Percutaneous Tibial Nerve Stimulation (pTNS) for Patients With Fecal Urge Incontinence |
- Fecal Incontinence [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
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
- Fecal Incontinence [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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
- Fecal Incontinence [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
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
- Fecal Incontinence [ Time Frame: before treatment, 6, 12, 32 wks after initial treatment ] [ Designated as safety issue: No ]
Vaizey Score (Gut (1999) 44:77)
- Fecal incontinence score similar to Wexner Score
- Anorectal manometric measurements [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]compared to pre-treatment values
- Quality of Life [ Time Frame: before treatment, 6, 32 wks after initial treatment ] [ Designated as safety issue: No ]
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
- Cost [ Time Frame: at the end of the treatment ] [ Designated as safety issue: No ]total cost of treatment will be evaluated (material, work hours etc)
- Adverse Events [ Time Frame: for each treatment interval ] [ Designated as safety issue: Yes ]
adverse events between treatments:
- pain, bleeding, neurological sensation, other AE
Adverse events during percutaneous nerve stimulation:
- pain, bleeding and discomfort
- Urinary incontinence [ Time Frame: before treatment, 6, 12, 32 wks after initial treatment ] [ Designated as safety issue: No ]
Hanley Score (BMJ (2001) 322:1096)
- Urinary incontinence score
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | March 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: pTNS treatment |
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).
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Christine Maurus, Dr. med. | +41 71 494 1111 | christine.maurus@kssg.ch |
| Contact: Ulrich Beutner, Ph.D. | +41 71 494 1111 | ulrich.beutner@kssg.ch |
| Switzerland | |
| Department of Surgery, Cantonal Hospital St. Gallen | Recruiting |
| St. Gallen, Switzerland, 9007 | |
| Contact: Christine Maurus, Dr. med +41 71 494 1111 christine.Maurus@kssg.ch | |
| Sub-Investigator: Christine Maurus, Dr. med. | |
| Principal Investigator: | Lukas T Marti, Dr. med. | Department of Surgery, Cantonal Hospital St. Gallen |
More Information
Additional Information:
No publications provided
| Responsible Party: | Lukas Marti, Attending physician, Cantonal Hospital of St. Gallen |
| ClinicalTrials.gov Identifier: | NCT01162525 History of Changes |
| Other Study ID Numbers: | pTNS |
| Study First Received: | July 13, 2010 |
| Last Updated: | May 6, 2013 |
| Health Authority: | Switzerland: Ethikkommission |
Keywords provided by Cantonal Hospital of St. Gallen:
|
Fecal Incontinence Fecal Urge Incontinence Percutaneous tibial nerve stimulation |
Additional relevant MeSH terms:
|
Fecal Incontinence Urinary Incontinence, Urge Rectal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
Urinary Incontinence Urination Disorders Urologic Diseases Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013