Sacral Neuromodulation and Pudendal Somatic Afferents

NCT ID: NCT03614754

Last Updated: 2019-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-01

Study Completion Date

2022-07-31

Brief Summary

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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

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Conditions

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Overactive Bladder, Non Obstructive Urinary Retention

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Successes

Patients with reduction of symptoms \>50% during the test procedure for sacral neuromodulation.

Somatosensory evoked potentials

Intervention Type DIAGNOSTIC_TEST

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

Failures

Patients with reduction of symptoms \<50% during the test procedure for sacral neuromodulation.

Somatosensory evoked potentials

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Somatosensory evoked potentials

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Overactive bladder
* Non-obstructive urinary retention

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universiteit Antwerpen

OTHER

Sponsor Role lead

Responsible Party

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Donald Vaganée

MD, PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Antwerp University Hospital

Edegem, Antwerp, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Donald A Vaganee, MD PhD student

Role: CONTACT

8213047 ext. 323

Stefan De Wachter, MD PhD FEBU

Role: CONTACT

8215934 ext. 323

Facility Contacts

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Stefan De Wachter, MD PhD FEABU

Role: primary

Other Identifiers

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17/30/334

Identifier Type: -

Identifier Source: org_study_id

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