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Sacral Neuromodulation and Pudendal Somatic Afferents

The Involvement of Pudendal Somatic Afferents in Sacral Neuromodulation Assessed by Somatosensory Evoked Potentials of the Pudendal Nerve

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03614754
Enrollment
40
Registered
2018-08-03
Start date
2017-08-01
Completion date
2022-07-31
Last updated
2019-10-15

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

Conditions

Overactive Bladder, Non Obstructive Urinary Retention

Brief summary

Sacral neuromodulation is a well-excepted minimally invasive procedure for the treatment of overactive bladder and non-obstructive urinary retention.A tined lead with 4 stimulation electrodes is placed through the third or fourth sacral foramen and stimulates sacral roots in its vicinity. Since the sacral roots are mixed nerves, it is currently still unknown which nerve fibers are stimulated (autonomic vs somatic, afferent vs efferent) and what the mechanism of action is. This study examines the involvement of pudendal somatic afferents by measuring somatosensory evoked potentials elicited by stimulation of the pudendal nerve.

Interventions

Stimulation of the pudendal nerve while recording at the sensory cortex.

Sponsors

Universiteit Antwerpen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Overactive bladder * Non-obstructive urinary retention

Exclusion criteria

* Neurogenic disorders (e.g. cerebrovascular accident, spinal cord injury,...)

Design outcomes

Primary

MeasureTime frameDescription
Latency change3 weeksLatency of somatosensory evoked potential are recorded before and after test procedure sacral neuromodulation expressed in milliseconds.

Countries

Belgium

Contacts

Primary ContactDonald A Vaganee, MD PhD student
donald.vaganee@uantwerpen.be8213047
Backup ContactStefan De Wachter, MD PhD FEBU
stefan.dewachter@uantwerpen.be8215934

Outcome results

None listed

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