Sacral Neuromodulation and Pudendal Somatic Afferents
- Conditions
- Overactive Bladder, Non Obstructive Urinary Retention
- Interventions
- Diagnostic Test: Somatosensory evoked potentials
- Registration Number
- NCT03614754
- Lead Sponsor
- Universiteit Antwerpen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- Overactive bladder
- Non-obstructive urinary retention
- Neurogenic disorders (e.g. cerebrovascular accident, spinal cord injury,...)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Failures Somatosensory evoked potentials Patients with reduction of symptoms \<50% during the test procedure for sacral neuromodulation. Successes Somatosensory evoked potentials Patients with reduction of symptoms \>50% during the test procedure for sacral neuromodulation.
- Primary Outcome Measures
Name Time Method Latency change 3 weeks Latency of somatosensory evoked potential are recorded before and after test procedure sacral neuromodulation expressed in milliseconds.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Antwerp University Hospital
🇧🇪Edegem, Antwerp, Belgium