Overactive Bladder, Non Obstructive Urinary Retention Clinical Trial
Official title:
The Involvement of Pudendal Somatic Afferents in Sacral Neuromodulation Assessed by Somatosensory Evoked Potentials of the Pudendal Nerve
| NCT number | NCT03614754 |
| Other study ID # | 17/30/334 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | August 1, 2017 |
| Est. completion date | July 31, 2022 |
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.
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | July 31, 2022 |
| Est. primary completion date | July 31, 2022 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Overactive bladder - Non-obstructive urinary retention Exclusion Criteria: - Neurogenic disorders (e.g. cerebrovascular accident, spinal cord injury,...) |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Antwerp University Hospital | Edegem | Antwerp |
| Lead Sponsor | Collaborator |
|---|---|
| Universiteit Antwerpen |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Latency change | Latency of somatosensory evoked potential are recorded before and after test procedure sacral neuromodulation expressed in milliseconds. | 3 weeks |