Fecal IncontinenceNCT01130870
Dose Response Curve - Sacral Nerve Stimulation for Faecal Incontinence
A study testing Sensory Threshold, 75% of sensory threshold - Amplitude and 50% of sensory threshold - Amplitude in people with Fecal Incontinence, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to determine if subsensory stimulation (amplitude) will maintain same continence in patients treated with Sacral Nerve Stimulation (SNS) for faecal incontinence as stimulation with amplitude at sensory threshold. 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?
- Sensory Threshold, 75% of sensory threshold - Amplitude and 50% of sensory threshold - Amplitude
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2010to Jun 2011
- 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
- 18 years or older
- Informed consent
- Idiopathic fecal incontinence or Fecal incontinence due to small sphincter defect(≤60 o)
- fecal incontinence after primary/secondary sphincter repair
- Permanent neuromodulator (medtronic InterStim / Interstim II) implanted for at least 12 weeks before entering the study.
- Reduction in fecal incontinence episodes of at least 75% between baseline and latest follow up.(Bowel diary card) or 75% reduction of Wexner Inc. score.
- Willing and competent to fill out diary cards
Who cannot join
- Colorectal/proctological surgery since IPG-implant
- Pregnancy
- Anorectal Pain
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital
Aarhus, Aarhus C, 8000
About this study
The purpose of this study is to determine if subsensory stimulation (amplitude) will maintain same continence in patients treated with Sacral Nerve Stimulation (SNS) for faecal incontinence as stimulation with amplitude at sensory threshold.
Read the detailed description
Faecal incontinence is a devastating condition with huge impact on quality of life. Sacral Nerve Stimulation (SNS) has since 1995 been a treatment option for patients not obtaining satisfactory continence result with standard non-surgical treatments. SNS is electrical stimulation of the sacral nerve root(s2,3 or 4). Stimulation of this nerve roots results in improved continence. The mechanism of action is at present not well described.
Standard the neuromodulator (pacemaker) stimulate with Frequency 14 Hz, pulse width 210 mic.sec. and amplitude set at sensory threshold. One study by SM. Koch et all confirms that subsensory stimulation can be effective. At present there is no doubled blinded study's to confirm this theory of effective sub sensory stimulation.
The aim of this study is to determine if subsensory stimulation will be as effective as stimulation with amplitude at sensory threshold. This will be investigated in 20 patients who have had at least a reduction in incontinence episodes or Wexner inc. score of 75 % between preimplantation and latest follow up. The patients will be randomized to three different amplitudes. 1: amplitude set at sensory threshold. 2: 75% of sensory threshold. 3: 50% of sensory threshold. The order of the three settings will be random and in a double blinded manner. The interval between these three pacemaker settings is four weeks. Patients serve as there own controls. Stimulation frequency (14 Hz) and pulse width (210 mic-sec) will remain fixed.
Evaluation will be by means of 4 week bowel habit diary and questionnaires (Wexner inc. score / St. Marks Score / Wexner constipation score / Altomares OD-score / IBS-score/ Rockwood FIQoL -score). All patients will be evaluated with anorectal measurements (sphincter strength and anorectal volume measurements) before any changes of stimulation amplitude.
- Conditions
- Fecal Incontinence
- Being tested
- Sensory Threshold, 75% of sensory threshold - Amplitude, 50% of sensory threshold - Amplitude
- Keywords
- Fecal incontinence, Sacral nerve stimulation, Quality of life, DR15.9 Incontinentia alva
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory ThresholdDevice
Sacral nerve stimulation with amplitude (sensory threshold), Frequency 14 Hz and pulse width 210 mic.sec.
75% of sensory threshold - AmplitudeDevice
Sacral nerve stimulation with amplitude (75% of sensory threshold), Frequency 14 Hz and pulse width 210 mic.sec.
50% of sensory threshold - AmplitudeDevice
Sacral nerve stimulation with amplitude (50% of sensory threshold), Frequency 14 Hz and pulse width 210 mic.sec.
| Study group | Role | What they receive |
|---|---|---|
| Sensory threshold - Amplitude | Active comparator | Stimulation amplitude set at sensory threshold. Receives: Device: Sensory Threshold |
| 25% below sensory threshold - Amplitude | Experimental | Stimulation amplitude 75% of sensory threshold. Receives: Device: 75% of sensory threshold - Amplitude |
| 50% below sensory threshold - Amplitude | Experimental | Stimulation with amplitude set 50% below sensory threshold Receives: Device: 50% of sensory threshold - Amplitude |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of incontinence episodes Assess number of incontinence episodes.
Assess number of incontinence episodes, by means of bowel habit diary. Four week bowel habit diary will be evaluated three times during the twelve-week protocol perioed.
Measured: Will be assessed every four weeks during a twelve-week period
Secondary outcomes (2)
Assess changes in anorectal volume and pressure with different amplitude.
Resting and maximal anal sphincter pressure will be measured with different amplitude settings. In total three evaluations will be made in the twelve week protocol perioed.
Measured: Will be assessed every four weeks during a twelve-week period
Assess Quality of life after decrease in stimulation amplitude.
Quality of life will be recorded by means of Rockwood faecal incontinence quality of life score. A total of three evaluations will be made every fourth week in the twelve week protocol perioed.
Measured: Will be assessed every four weeks during a twelve-week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01130870
- Sponsor's protocol ID
- 002
- Other IDs
- 002
- Status last verified
- Nov 2011
- First submitted
- 14 May 2010
- Last updated
- 10 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Duelund-Jakobsen J, Buntzen S, Lundby L, Laurberg S. Sacral nerve stimulation at subsensory threshold does not compromise treatment efficacy: results from a randomized, blinded crossover study. Ann Surg. 2013 Feb;257(2):219-23. doi: 10.1097/SLA.0b013e318269d493.
PubMed 23001079
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Response Curve - Sacral Nerve Stimulation for Faecal Incontinence
- ClinicalTrials.gov ID
- NCT01130870
- Acronym / sponsor ID
- 002
- Conditions
- Fecal Incontinence
- Keywords
- Fecal incontinence, Sacral nerve stimulation, Quality of life, DR15.9 Incontinentia alva
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 26 May 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.
The purpose of this study is to determine if subsensory stimulation (amplitude) will maintain same continence in patients treated with Sacral Nerve Stimulation (SNS) for faecal incontinence as stimulation with amplitude at sensory threshold.
Detailed description
Faecal incontinence is a devastating condition with huge impact on quality of life. Sacral Nerve Stimulation (SNS) has since 1995 been a treatment option for patients not obtaining satisfactory continence result with standard non-surgical treatments. SNS is electrical stimulation of the sacral nerve root(s2,3 or 4). Stimulation of this nerve roots results in improved continence. The mechanism of action is at present not well described.
Standard the neuromodulator (pacemaker) stimulate with Frequency 14 Hz, pulse width 210 mic.sec. and amplitude set at sensory threshold. One study by SM. Koch et all confirms that subsensory stimulation can be effective. At present there is no doubled blinded study's to confirm this theory of effective sub sensory stimulation.
The aim of this study is to determine if subsensory stimulation will be as effective as stimulation with amplitude at sensory threshold. This will be investigated in 20 patients who have had at least a reduction in incontinence episodes or Wexner inc. score of 75 % between preimplantation and latest follow up. The patients will be randomized to three different amplitudes. 1: amplitude set at sensory threshold. 2: 75% of sensory threshold. 3: 50% of sensory threshold. The order of the three settings will be random and in a double blinded manner. The interval between these three pacemaker settings is four weeks. Patients serve as there own controls. Stimulation frequency (14 Hz) and pulse width (210 mic-sec) will remain fixed.
Evaluation will be by means of 4 week bowel habit diary and questionnaires (Wexner inc. score / St. Marks Score / Wexner constipation score / Altomares OD-score / IBS-score/ Rockwood FIQoL -score). All patients will be evaluated with anorectal measurements (sphincter strength and anorectal volume measurements) before any changes of stimulation amplitude.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sensory threshold - Amplitude | Active comparator | Device: Sensory ThresholdStimulation amplitude set at sensory threshold. |
| 25% below sensory threshold - Amplitude | Experimental | Device: 75% of sensory threshold - AmplitudeStimulation amplitude 75% of sensory threshold. |
| 50% below sensory threshold - Amplitude | Experimental | Device: 50% of sensory threshold - AmplitudeStimulation with amplitude set 50% below sensory threshold |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years or older
- Informed consent
- Idiopathic fecal incontinence or Fecal incontinence due to small sphincter defect(≤60 o)
- fecal incontinence after primary/secondary sphincter repair
- Permanent neuromodulator (medtronic InterStim / Interstim II) implanted for at least 12 weeks before entering the study.
Key exclusion criteria (3 listed)
- Colorectal/proctological surgery since IPG-implant
- Pregnancy
- Anorectal Pain
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 |
|---|---|---|
| Sensory ThresholdSacral nerve stimulation with amplitude (sensory threshold), Frequency 14 Hz and pulse width 210 mic.sec. | Device | Sensory threshold - Amplitude |
| 75% of sensory threshold - AmplitudeSacral nerve stimulation with amplitude (75% of sensory threshold), Frequency 14 Hz and pulse width 210 mic.sec. | Device | 25% below sensory threshold - Amplitude |
| 50% of sensory threshold - AmplitudeSacral nerve stimulation with amplitude (50% of sensory threshold), Frequency 14 Hz and pulse width 210 mic.sec. | Device | 50% below sensory threshold - Amplitude |
Primary outcome
Number of incontinence episodes Assess number of incontinence episodes.
Time frame: Will be assessed every four weeks during a twelve-week period
Assess number of incontinence episodes, by means of bowel habit diary. Four week bowel habit diary will be evaluated three times during the twelve-week protocol perioed.
2 secondary outcomes
Assess changes in anorectal volume and pressure with different amplitude.
Time frame: Will be assessed every four weeks during a twelve-week period
Assess Quality of life after decrease in stimulation amplitude.
Time frame: Will be assessed every four weeks during a twelve-week period
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 10 Nov 2011.
- Derived from this study: PubMed 23001079Duelund-Jakobsen J, Buntzen S, Lundby L, Laurberg S. Sacral nerve stimulation at subsensory threshold does not compromise treatment efficacy: results from a randomized, blinded crossover study. Ann Surg. 2013 Feb;257(2):219-23. doi: 10.1097/SLA.0b013e318269d493.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory Threshold, 75% of sensory threshold - Amplitude and 50% of sensory threshold - Amplitude in people with Fecal Incontinence, run by University of Aarhus at 1 site in Denmark.
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 7 inclusion and 3 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 10 Nov 2011. 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 Denmark. 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?
Number of incontinence episodes Assess number of incontinence episodes. (time frame: Will be assessed every four weeks during a twelve-week period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01130870, which also lists 1 linked publication.
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 10 Nov 2011.