Fecal IncontinenceNCT01162525
Percutaneous Tibial Nerve Stimulation for Patients With Fecal Incontinence
A study testing Percutaneous tibial nerve stimulation (pTNS) in people with Fecal Incontinence, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Percutaneous tibial nerve stimulation (pTNS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2010to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- fecal urge incontinence
- conservative treatment has been performed without success
Who cannot join
- current anticoagulation treatment
- sphincter defects larger than 120°
- pregnancy
- pace maker
- implanted defibrillators
- severe heart disease
- existing neurological damages
- disposition for strong bleeding
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Surgery, Cantonal Hospital St. Gallen
Sankt Gallen, 9007
About this study
Official title: Percutaneous Tibial Nerve Stimulation (pTNS) for Patients With Fecal Urge Incontinence
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.
Read the 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
- Being tested
- Percutaneous tibial nerve stimulation (pTNS)
- Keywords
- Fecal Incontinence, Fecal Urge Incontinence, Percutaneous tibial nerve stimulation
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous tibial nerve stimulation (pTNS)Procedure or surgery
Also called pTNS, peripheral tibial nerve stimulation, peripheral neuromodulation
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).
| Study group | Role | What they receive |
|---|---|---|
| pTNS treatment | Experimental | Not described Receives: Procedure: Percutaneous tibial nerve stimulation (pTNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
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
Measured: 12 weeks
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
Measured: 32 weeks
Secondary outcomes (6)
Fecal Incontinence
Vaizey Score (Gut (1999) 44:77)
- Fecal incontinence score similar to Wexner Score
Measured: before treatment, 6, 12, 32 wks after initial treatment
Anorectal manometric measurements
compared to pre-treatment values
Measured: 12 weeks
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
Measured: before treatment, 6, 32 wks after initial treatment
Cost
total cost of treatment will be evaluated (material, work hours etc)
Measured: at the end of the treatment
Adverse Events
adverse events between treatments:
- pain, bleeding, neurological sensation, other AE
Adverse events during percutaneous nerve stimulation:
- pain, bleeding and discomfort
Measured: for each treatment interval
Urinary incontinence
Hanley Score (BMJ (2001) 322:1096)
- Urinary incontinence score
Measured: before treatment, 6, 12, 32 wks after initial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2010 (estimated)
- Study startJan 2010
- Primary completionOct 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lukas Marti, Cantonal Hospital of St. Gallen
- Investigators
- Lukas T Marti, Dr. med., Principal investigator, Department of Surgery, Cantonal Hospital St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01162525
- Sponsor's protocol ID
- pTNS
- Status last verified
- Sep 2018
- First submitted
- 13 Jul 2010
- Last updated
- 19 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Tibial Nerve Stimulation (pTNS) for Patients With Fecal Urge Incontinence
- ClinicalTrials.gov ID
- NCT01162525
- Acronym / sponsor ID
- pTNS
- Conditions
- Fecal Incontinence
- Keywords
- Fecal Incontinence, Fecal Urge Incontinence, Percutaneous tibial nerve stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Oct 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 14 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pTNS treatment | Experimental | Procedure: Percutaneous tibial nerve stimulation (pTNS) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- fecal urge incontinence
- conservative treatment has been performed without success
Key exclusion criteria (8 listed)
- current anticoagulation treatment
- sphincter defects larger than 120°
- pregnancy
- pace maker
- implanted defibrillators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous tibial nerve stimulation (pTNS)Also: pTNS, peripheral tibial nerve stimulation, peripheral neuromodulationA 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). | Procedure or surgery | pTNS treatment |
Primary outcome
Fecal Incontinence
Time frame: 6 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
Fecal Incontinence
Time frame: 12 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
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
6 secondary outcomes
Fecal Incontinence
Time frame: before treatment, 6, 12, 32 wks after initial treatment
Anorectal manometric measurements
Time frame: 12 weeks
Quality of Life
Time frame: before treatment, 6, 32 wks after initial treatment
Cost
Time frame: at the end of the treatment
Adverse Events
Time frame: for each treatment interval
Urinary incontinence
Time frame: before treatment, 6, 12, 32 wks after initial treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
- Website of the Department of Surgery, Cantonal Hospital of St. Gallen (German only)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lukas T Marti, Dr. med. principal investigator
Department of Surgery, Cantonal Hospital St. Gallen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous tibial nerve stimulation (pTNS) in people with Fecal Incontinence, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal Incontinence (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2018.