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Sacral Neuromodulation and Pudendal Somatic Afferents

U

Universiteit Antwerpen

Status

Unknown

Conditions

Overactive Bladder, Non Obstructive Urinary Retention

Treatments

Diagnostic Test: Somatosensory evoked potentials

Study type

Observational

Funder types

Other

Identifiers

NCT03614754
17/30/334

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Overactive bladder
  • Non-obstructive urinary retention

Exclusion criteria

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

Trial design

40 participants in 2 patient groups

Successes
Description:
Patients with reduction of symptoms \>50% during the test procedure for sacral neuromodulation.
Treatment:
Diagnostic Test: Somatosensory evoked potentials
Failures
Description:
Patients with reduction of symptoms \<50% during the test procedure for sacral neuromodulation.
Treatment:
Diagnostic Test: Somatosensory evoked potentials

Trial contacts and locations

1

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Central trial contact

Stefan De Wachter, MD PhD FEBU; Donald A Vaganee, MD PhD student

Data sourced from clinicaltrials.gov

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