Faecal IncontinenceNCT04726904
Best Surgical Technique for Optimal Lead Placement in Sacral Neuromodulation - a Comparative Cadaver Study
A study testing Sacral neuromodulation in conventional implantation technique in people with Faecal Incontinence, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Sacral neuromodulation (SNM) is an established treatment option for patients with faecal incontinence. The location of the stimulating electrode is considered to be essential for treatment success. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Faecal Incontinence
- What is being tested?
- Sacral neuromodulation in conventional implantation technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteAustria
- Study dates
- 17 Dec 2020to 15 Aug 2021
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cadaver study
- All of these individuals had donated their bodies to medical education and research in form of an informed consent.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Christopher Dawoud, MD, christopher.dawoud@meduniwien.ac.at
About this study
Sacral neuromodulation (SNM) is an established treatment option for patients with faecal incontinence. The location of the stimulating electrode is considered to be essential for treatment success. The purpose of this study was to evaluate the position of SNM electrodes after using the conventional implantation technique and to compare our results with those of the preliminary study, where the standardised fluoroscopy-guided implantation technique was used.
In this cadaver study, SNM electrodes will be implanted bilaterally in 5 lower body specimens. After electrode placement the pelvis was dissected to describe the exact position of the SNM electrodes.
Read the detailed description
Sacral neuromodulation (SNM) is an established treatment option for patients with faecal incontinence. The location of the stimulating electrode is considered to be essential for treatment success. The purpose of this study was to evaluate the position of SNM electrodes after using the conventional implantation technique and to compare our results with those of the preliminary study, where the standardised fluoroscopy-guided implantation technique was used.
However, to date no studies exist comparing different surgical techniques. The present cadaver study was designed to assess the distance between lead and sacral nerves by comparing two different surgical techniques: the new fluoroscopy guided "H" technique and the commonly conducted non radiological lead implantation using anatomical landmarks.
In this cadaver study, SNM electrodes will be implanted bilaterally in 5 lower body specimens.Afterwards the cadaver will be dissected and the exact location to the nerve, as well as a perforation of the sacral fascia will be noted.
The results will be compared to the preliminary study of Mueller et al., where they used the new fluoroscopy guided "H" technique in five cadavers.
- Conditions
- Faecal Incontinence
- Being tested
- Sacral neuromodulation in conventional implantation technique
- Medical subject headings
- Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacral neuromodulation in conventional implantation techniqueProcedure or surgery
Sacral neuromodulation is implanted with the patients in a prone position, then the insert point of the needle is decided according to anatomical landmarks; afterwards, the lead will be inserted.
| Study group | Role | What they receive |
|---|---|---|
| Conventional lead placement | Other | The cadaver is placed in the prone position. The exact location for insertion of the needle is defined with the conventional technique. Receives: Procedure: Sacral neuromodulation in conventional implantation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance lead to nerve
The exact distance (mm) will be assessed from the lead to the nerve
Measured: 1 week
Secondary outcomes (2)
Neuroforamen
The inserted neuroforamen will be assessed.
Measured: 1 week
Sacral fascia
A perforation throw the sacral fascia will be noted.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start17 Dec 2020
- Primary completion15 Aug 2021 (estimated)
- Study completion15 Aug 2021 (estimated)
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 Faecal IncontinenceStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Christopher Dawoud, Medical University of Vienna
- Investigators
- Christopher Dawoud, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726904
- Sponsor's protocol ID
- 2219/2018
- Status last verified
- Aug 2021
- First submitted
- 23 Jan 2021
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Muller C, Reissig LF, Argeny S, Weninger WJ, Riss S. Standardized fluoroscopy-guided implantation technique enables optimal electrode placement in sacral neuromodulation: a cadaver study. Tech Coloproctol. 2021 Feb;25(2):215-221. doi: 10.1007/s10151-020-02364-w. Epub 2020 Nov 19.
PubMed 33211205
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Best Surgical Technique for Optimal Lead Placement in Sacral Neuromodulation - a Comparative Cadaver Study
- ClinicalTrials.gov ID
- NCT04726904
- Acronym / sponsor ID
- 2219/2018
- Conditions
- Faecal Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 15 Aug 2021 (estimated)
- Study completion
- 15 Aug 2021 (estimated)
- First posted
- 27 Jan 2021 (actual)
- 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.
Sacral neuromodulation (SNM) is an established treatment option for patients with faecal incontinence. The location of the stimulating electrode is considered to be essential for treatment success. The purpose of this study was to evaluate the position of SNM electrodes after using the conventional implantation technique and to compare our results with those of the preliminary study, where the standardised fluoroscopy-guided implantation technique was used.
In this cadaver study, SNM electrodes will be implanted bilaterally in 5 lower body specimens. After electrode placement the pelvis was dissected to describe the exact position of the SNM electrodes.
Detailed description
Sacral neuromodulation (SNM) is an established treatment option for patients with faecal incontinence. The location of the stimulating electrode is considered to be essential for treatment success. The purpose of this study was to evaluate the position of SNM electrodes after using the conventional implantation technique and to compare our results with those of the preliminary study, where the standardised fluoroscopy-guided implantation technique was used.
However, to date no studies exist comparing different surgical techniques. The present cadaver study was designed to assess the distance between lead and sacral nerves by comparing two different surgical techniques: the new fluoroscopy guided "H" technique and the commonly conducted non radiological lead implantation using anatomical landmarks.
In this cadaver study, SNM electrodes will be implanted bilaterally in 5 lower body specimens.Afterwards the cadaver will be dissected and the exact location to the nerve, as well as a perforation of the sacral fascia will be noted.
The results will be compared to the preliminary study of Mueller et al., where they used the new fluoroscopy guided "H" technique in five cadavers.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Conventional lead placement | Other | Procedure: Sacral neuromodulation in conventional implantation techniqueThe cadaver is placed in the prone position. The exact location for insertion of the needle is defined with the conventional technique. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cadaver study
- All of these individuals had donated their bodies to medical education and research in form of an informed consent.
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Sacral neuromodulation in conventional implantation techniqueSacral neuromodulation is implanted with the patients in a prone position, then the insert point of the needle is decided according to anatomical landmarks; afterwards, the lead will be inserted. | Procedure or surgery | Conventional lead placement |
Primary outcome
Distance lead to nerve
Time frame: 1 week
The exact distance (mm) will be assessed from the lead to the nerve
2 secondary outcomes
Neuroforamen
Time frame: 1 week
Sacral fascia
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Background: PubMed 33211205Muller C, Reissig LF, Argeny S, Weninger WJ, Riss S. Standardized fluoroscopy-guided implantation technique enables optimal electrode placement in sacral neuromodulation: a cadaver study. Tech Coloproctol. 2021 Feb;25(2):215-221. doi: 10.1007/s10151-020-02364-w. Epub 2020 Nov 19.
- Individual participant dataSharing planned: Undecided
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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.
Christopher Dawoud, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacral neuromodulation in conventional implantation technique in people with Faecal Incontinence, run by Medical University of Vienna at 1 site in Austria.
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 1 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 3 Aug 2021. 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 Austria. 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 Christopher Dawoud, MD (0043660 280 48 39, christopher.dawoud@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance lead to nerve (time frame: 1 week). 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 NCT04726904, 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 3 Aug 2021.