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Best Surgical Technique for Optimal Lead Placement in Sacral Neuromodulation - a Comparative Cadaver Study

Best Surgical Technique for Optimal Lead Placement in Sacral Neuromodulation - a Comparative Cadaver Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04726904
Enrollment
5
Registered
2021-01-27
Start date
2020-12-17
Completion date
2021-08-15
Last updated
2021-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Faecal Incontinence

Brief 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. 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.

Interventions

PROCEDURESacral neuromodulation in conventional implantation technique

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.

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* Cadaver study * All of these individuals had donated their bodies to medical education and research in form of an informed consent.

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Distance lead to nerve1 weekThe exact distance (mm) will be assessed from the lead to the nerve

Secondary

MeasureTime frameDescription
Neuroforamen1 weekThe inserted neuroforamen will be assessed.
Sacral fascia1 weekA perforation throw the sacral fascia will be noted.

Countries

Austria

Contacts

Primary ContactChristopher Dawoud, MD
christopher.dawoud@meduniwien.ac.at0043660 280 48 39

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026