Fecal IncontinenceNCT02888899
Tibial Nerve Stimulation in Combination With Biofeedback
A study testing Biofeedback, Loperamide and Stool bulking agent (sterculia or ispaghula husk) in people with Fecal Incontinence, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
Background: Fecal incontinence (FI) affects 2-13% of an adult general population. The prevalence increases with age, and after 50 years of age prevalence rates up to 26% in women have been reported. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Biofeedback, Loperamide and Stool bulking agent (sterculia or ispaghula husk)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteSweden
- Study dates
- Mar 2016to Mar 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years of age with fecal incontinence for more than 6 months
- Patients with at least one or more episodes of fecal incontinence during a period of 2 weeks as recorded by bowel function diary
- Patients from whom written consent was obtained
Who cannot join
- Previous congenital or acquired spinal injury, spinal tumour or spinal surgery
- Presence of neurological diseases or peripheral vascular disease
- Uncontrolled diabetes mellitus
- Congenital anorectal malformations
- Colorectal or gastrointestinal surgery ≤24 months
- Presence of external full-thickness rectal prolapse
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- Inflammatory bowel disease
- Chronic diarrhoea
- Use of tibial nerve or sacral nerve stimulations
- Ongoing pregnancy
- Any malignant disease
- Pacemaker
- Ongoing or earlier treatment with sacral- or tibial nerve stimulation
- Chronic varicose ulcer
Trial locations and contacts
1 site in 1 country.
Susanna Walter, PhD, MD contact
Sweden1 site, 1 recruiting
- Recruiting
Pelvic floor unit, University Hospital in Linköping
Linköping, 58185
Jenny Sjödahl, PhD, RPT, +46 706 83 46 37, jenny.sjodahl@liu.se
Susanna Walter, PhD, MD, +46 702 43 00 03, susanna.walter@liu.se
About this study
Official title: Percutaneous Tibial Nerve Stimulation in Combination With Biofeedback in Patients With Fecal Incontinence - A Randomized Controlled Trial
Background: Fecal incontinence (FI) affects 2-13% of an adult general population. The prevalence increases with age, and after 50 years of age prevalence rates up to 26% in women have been reported. Quality of life in patients with FI is decreased considerably, in a similar extent as in patients with ulcerative colitis in relapse.
Management of FI usually involves a stepwise approach; beginning with more conservative strategies and moving on to more appropriately tailored medications, bowel-retraining, biofeedback and psychosocial support. Although a combination of these treatment alternatives often improves symptoms they are not always successfully. Neuromodulation is a relatively new treatment modality for FI that is based on recruitment of residual anorectal neuromuscular function pertinent to continence by electrical stimulation of the peripheral nerve supply. Sacral Nerve Stimulation (SNS) is one type of neuromodulation and it employs direct electrical stimulation of the sacral nerves. Recently an alternative neuromodulation technique to SNS has been developed in treating FI i.e. tibial nerve stimulation. The tibial nerve contains afferent and efferent fibers originating from the forth and the fifth lumbar nerves and the first, second and third sacral nerves. Thus, stimulation of the tibial nerve may lead to changes in anorectal neuromuscular function similar to those observed with SNS but without the need of a permanent surgically implanted device. Tibial nerve stimulation is therefore an attractive treatment alternative for FI patients since the treatment is well-tolerated and treatment results have been very promising.
Read more
Aim: The overall aim is to measure the effect of percutaneous tibial nerve stimulation (PTNS) in combination with biofeedback on symptoms in consecutive FI patients compared with biofeedback alone. The investigators also aim to study which FI patients have most profit of the addition of PTNS.
Methods: The study will take place at the Pelvic Floor Unit, department of Gastroenterology, University Hospital Linköping. Prior to the first visit to the hospital a symptom diary will be mailed to the FI patients and they are instructed to record their FI symptoms, bowel habits and gastrointestinal symptoms prospectively on a 24-hour diary during 2 weeks. Before consideration of enrolment into the study, gastroenterologists assess all the patients' medical history and perform a physical examination. Subjects will also have an endoanal ultrasonography and the investigators will measure rectal volumes, sensational thresholds and anal sphincter function.
FI patients who fulfil inclusion criteria will then be randomly assigned to either PTNS in combination with biofeedback or biofeedback alone. The treatment will be performed by physiotherapists.
- Conditions
- Fecal Incontinence
- Being tested
- Biofeedback, Loperamide, Stool bulking agent (sterculia or ispaghula husk), PTNS
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiofeedbackBehavioural
LoperamideDrug
Stool bulking agent (sterculia or ispaghula husk)Drug
PTNSOther
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment | Experimental | Not described Receives: Behavioral: Biofeedback; Drug: Loperamide; Drug: Stool bulking agent (sterculia or ispaghula husk) |
| PTNS in addition to standard treatment | Experimental | Not described Receives: Behavioral: Biofeedback; Drug: Loperamide; Drug: Stool bulking agent (sterculia or ispaghula husk); Other: PTNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fecal leakage episodes with a symptom diary
Measured: Change from baseline in fecal leakage episodes at 12 weeks (post-treatment), change from baseline in fecal lekage episodes at 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2018 (estimated)
- Study completionMar 2019 (estimated)
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
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenny Sjödahl, University Hospital, Linkoeping
- Investigators
- Jenny Sjödahl, PhD, RPT, Principal investigator, University Hospital in Linkoeping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888899
- Sponsor's protocol ID
- Dnr 2015/443-31
- Status last verified
- Aug 2016
- First submitted
- 23 Aug 2016
- Last updated
- 5 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Tibial Nerve Stimulation in Combination With Biofeedback in Patients With Fecal Incontinence - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02888899
- Acronym / sponsor ID
- Dnr 2015/443-31
- Conditions
- Fecal Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 5 Sep 2016 (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.
Background: Fecal incontinence (FI) affects 2-13% of an adult general population. The prevalence increases with age, and after 50 years of age prevalence rates up to 26% in women have been reported. Quality of life in patients with FI is decreased considerably, in a similar extent as in patients with ulcerative colitis in relapse.
Management of FI usually involves a stepwise approach; beginning with more conservative strategies and moving on to more appropriately tailored medications, bowel-retraining, biofeedback and psychosocial support. Although a combination of these treatment alternatives often improves symptoms they are not always successfully. Neuromodulation is a relatively new treatment modality for FI that is based on recruitment of residual anorectal neuromuscular function pertinent to continence by electrical stimulation of the peripheral nerve supply. Sacral Nerve Stimulation (SNS) is one type of neuromodulation and it employs direct electrical stimulation of the sacral nerves. Recently an alternative neuromodulation technique to SNS has been developed in treating FI i.e. tibial nerve stimulation. The tibial nerve contains afferent and efferent fibers originating from the forth and the fifth lumbar nerves and the first, second and third sacral nerves. Thus, stimulation of the tibial nerve may lead to changes in anorectal neuromuscular function similar to those observed with SNS but without the need of a permanent surgically implanted device. Tibial nerve stimulation is therefore an attractive treatment alternative for FI patients since the treatment is well-tolerated and treatment results have been very promising.
Aim: The overall aim is to measure the effect of percutaneous tibial nerve stimulation (PTNS) in combination with biofeedback on symptoms in consecutive FI patients compared with biofeedback alone. The investigators also aim to study which FI patients have most profit of the addition of PTNS.
Methods: The study will take place at the Pelvic Floor Unit, department of Gastroenterology, University Hospital Linköping. Prior to the first visit to the hospital a symptom diary will be mailed to the FI patients and they are instructed to record their FI symptoms, bowel habits and gastrointestinal symptoms prospectively on a 24-hour diary during 2 weeks. Before consideration of enrolment into the study, gastroenterologists assess all the patients' medical history and perform a physical examination. Subjects will also have an endoanal ultrasonography and the investigators will measure rectal volumes, sensational thresholds and anal sphincter function.
FI patients who fulfil inclusion criteria will then be randomly assigned to either PTNS in combination with biofeedback or biofeedback alone. The treatment will be performed by physiotherapists.
Study design
- Primary purpose
- Treatment
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment | Experimental | Behavioral: Biofeedback, Drug: Loperamide, Drug: Stool bulking agent (sterculia or ispaghula husk) |
| PTNS in addition to standard treatment | Experimental | Behavioral: Biofeedback, Drug: Loperamide, Drug: Stool bulking agent (sterculia or ispaghula husk), Other: PTNS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients older than 18 years of age with fecal incontinence for more than 6 months
- Patients with at least one or more episodes of fecal incontinence during a period of 2 weeks as recorded by bowel function diary
- Patients from whom written consent was obtained
Key exclusion criteria (14 listed)
- Previous congenital or acquired spinal injury, spinal tumour or spinal surgery
- Presence of neurological diseases or peripheral vascular disease
- Uncontrolled diabetes mellitus
- Congenital anorectal malformations
- Colorectal or gastrointestinal surgery ≤24 months
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 |
|---|---|---|
| Biofeedback | Behavioural | PTNS in addition to standard treatment, Standard treatment |
| Loperamide | Drug | PTNS in addition to standard treatment, Standard treatment |
| Stool bulking agent (sterculia or ispaghula husk) | Drug | PTNS in addition to standard treatment, Standard treatment |
| PTNS | Other | PTNS in addition to standard treatment |
Primary outcome
Change in fecal leakage episodes with a symptom diary
Time frame: Change from baseline in fecal leakage episodes at 12 weeks (post-treatment), change from baseline in fecal lekage episodes at 12 months and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2016.
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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.
Susanna Walter, PhD, MD contact
Jenny Sjödahl, PhD, RPT principal investigator
University Hospital in Linkoeping
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback, Loperamide and Stool bulking agent (sterculia or ispaghula husk) in people with Fecal Incontinence, run by University Hospital, Linkoeping at 1 site in Sweden.
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 3 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 5 Sep 2016. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jenny Sjödahl, PhD, RPT (+46 706 83 46 37, jenny.sjodahl@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fecal leakage episodes with a symptom diary (time frame: Change from baseline in fecal leakage episodes at 12 weeks (post-treatment), change from baseline in fecal lekage episodes at 12 months and 24 months). 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 5 Sep 2016.