Sacral Neuromodulation and Pudendal Somatic Afferents

NCT03614754 | Unknown

• 1 other identifier: 17/30/334
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder, Non Obstructive Urinary Retention

Outcome Measures

Primary Outcomes (1)

• Latency change

  Latency of somatosensory evoked potential are recorded before and after test procedure sacral neuromodulation expressed in milliseconds.

  3 weeks

Study Arms (2)

Successes

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

Diagnostic Test: Somatosensory evoked potentials

Failures

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

Diagnostic Test: Somatosensory evoked potentials

Interventions

Somatosensory evoked potentials DIAGNOSTIC_TEST

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

Failures; Successes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Overactive bladder
• Non-obstructive urinary retention

You may not qualify if:

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

Sponsors & Collaborators

• Universiteit Antwerpen: lead

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Evoked Potentials, Somatosensory

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Evoked Potentials; Cortical Excitability; Electrophysiological Phenomena; Physiological Phenomena; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Donald A Vaganee, MD PhD student

CONTACT

8213047; donald.vaganee@uantwerpen.be

Stefan De Wachter, MD PhD FEBU

CONTACT

8215934; stefan.dewachter@uantwerpen.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD student

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 3, 2018
• Study Start: August 1, 2017
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: October 15, 2019

Record last verified: 2019-10

Locations

BE (1)