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Sacral Neuromodulation and Pudendal Somatic Afferents

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ClinicalTrials.gov Identifier: NCT03614754
Recruitment Status : Recruiting
First Posted : August 3, 2018
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Donald Vaganée, Universiteit Antwerpen

Study Description
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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.


Condition or disease Intervention/treatment
Overactive Bladder, Non Obstructive Urinary Retention Diagnostic Test: Somatosensory evoked potentials

Study Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Involvement of Pudendal Somatic Afferents in Sacral Neuromodulation Assessed by Somatosensory Evoked Potentials of the Pudendal Nerve
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022
Groups and Cohorts
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Group/Cohort Intervention/treatment
Successes
Patients with reduction of symptoms >50% during the test procedure for sacral neuromodulation.
 Diagnostic Test: Somatosensory evoked potentials
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.
 Diagnostic Test: Somatosensory evoked potentials
Stimulation of the pudendal nerve while recording at the sensory cortex.


Outcome Measures
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Primary Outcome Measures :
  1. Latency change [ Time Frame: 3 weeks ]
    Latency of somatosensory evoked potential are recorded before and after test procedure sacral neuromodulation expressed in milliseconds.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Urological patients with overactive bladder or non-obstructive urinary retention.
Criteria

Inclusion Criteria:

  • Overactive bladder
  • Non-obstructive urinary retention

Exclusion Criteria:

  • Neurogenic disorders (e.g. cerebrovascular accident, spinal cord injury,...)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03614754


Contacts
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Contact: Donald A Vaganee, MD PhD student 8213047 ext 323 donald.vaganee@uantwerpen.be
Contact: Stefan De Wachter, MD PhD FEBU 8215934 ext 323 stefan.dewachter@uantwerpen.be

Locations
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Belgium
Antwerp University Hospital Recruiting
Edegem, Antwerp, Belgium, 2650
Contact: Stefan De Wachter, MD PhD FEABU         
Sponsors and Collaborators
Universiteit Antwerpen
More Information
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Responsible Party: Donald Vaganée, MD, PhD student, Universiteit Antwerpen
ClinicalTrials.gov Identifier: NCT03614754    
Other Study ID Numbers: 17/30/334
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Retention
Urinary Bladder Diseases
Urologic Diseases
 Lower Urinary Tract Symptoms
Urological Manifestations
Urination Disorders