Sacral Neuromodulation and Pudendal Somatic Afferents | NCT03614754

Studies
Sacral Neuromodulation and Pudendal Somatic Afferents

NCT03614754

Sponsor

Universiteit Antwerpen

Status

Unknown status

Last Update Posted

Oct 15, 2019Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Overactive Bladder, Non Obstructive Urinary Retention

Interventions

Somatosensory evoked potentials

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2017Actual

Primary Completion Date

Jul 31, 2022Estimated

Completion Date

Jul 31, 2022Estimated

First Submitted Date

Jul 30, 2018

First Submission Date that Met QC Criteria

Aug 2, 2018

First Posted Date

Aug 3, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2019

Last Update Posted Date

Oct 15, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Somatosensory evoked potentials	Diagnostic Test	Stimulation of the pudendal nerve while recording at the sensory cortex.	Failures Successes

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Overactive bladder
Non-obstructive urinary retention

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Donald A Vaganee, MD PhD student	Contact	8213047	323	donald.vaganee@uantwerpen.be
Stefan De Wachter, MD PhD FEBU	Contact	8215934	323	stefan.dewachter@uantwerpen.be

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Antwerp University Hospital	Recruiting	Edegem	Antwerp	2650	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D053201	Urinary Bladder, Overactive

Ancestor Terms

ID	Term
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005073	Evoked Potentials, Somatosensory

Ancestor Terms

ID	Term
D005071	Evoked Potentials
D000071080	Cortical Excitability
D055724	Electrophysiological Phenomena
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided