Sacral Neuromodulation and Pudendal Somatic Afferents

The Involvement of Pudendal Somatic Afferents in Sacral Neuromodulation Assessed by Somatosensory Evoked Potentials of the Pudendal Nerve

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.

Study Overview

• Status: Unknown
• Conditions: Overactive Bladder, Non Obstructive Urinary Retention
• Intervention / Treatment: Diagnostic test: Somatosensory evoked potentials

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Donald A Vaganee, MD PhD student; Phone Number: 323 8213047; Email: donald.vaganee@uantwerpen.be
• Study Contact Backup: Name: Stefan De Wachter, MD PhD FEBU; Phone Number: 323 8215934; Email: stefan.dewachter@uantwerpen.be

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Recruiting
      • Antwerp University Hospital
      • Contact: Stefan De Wachter, MD PhD FEABU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Urological patients with overactive bladder or non-obstructive urinary retention.

Description

Inclusion Criteria:

• Overactive bladder
• Non-obstructive urinary retention

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Latency change	Latency of somatosensory evoked potential are recorded before and after test procedure sacral neuromodulation expressed in milliseconds.	3 weeks

Collaborators and Investigators

• Sponsor: Universiteit Antwerpen

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Anticipated): July 31, 2022
• Study Completion (Anticipated): July 31, 2022

Study Registration Dates

• First Submitted: July 30, 2018
• First Submitted That Met QC Criteria: August 2, 2018
• First Posted (Actual): August 3, 2018

Study Record Updates

• Last Update Posted (Actual): October 15, 2019
• Last Update Submitted That Met QC Criteria: October 13, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Bladder, Overactive; Urinary Retention
• Other Study ID Numbers: 17/30/334

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No