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Pudendal Nerve Mapping Towards Improved Neuromodulation for Urinary Retention

Primary Purpose

Urinary Retention, Underactive Bladder

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Medtronic Interstim II Model 3058 Neurostimulator

About this trial

This is an interventional basic science trial for Urinary Retention focused on measuring pudendal nerve mapping

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinically referred as having bladder problems that have not responded to conservative treatment. Normal clinical care includes referral to implant of Medtronic Interstim neurostimulator at the pudendal nerve. Fully eligible to receive an Interstim implant.
Adult (18 or older), capable of providing own informed consent and communicating clearly with research team
Capable of speaking, reading, and understanding English, as all study questionnaires are standardized assessments only available in English
Capable of attending all experimental sessions (Visit 1: pre-stage-1 imaging, Visit 2: stage-1 surgery, Visit 3: CT after stage-2 surgery, Visit 3: cystometrogram test)

Exclusion

Implanted materials that prohibit magnetic imaging
Any medical problems that prevent an individual from laying flat in an MRI or CT scanner, are are claustrophobic.
Areflexive or atonic bladder
Pregnant or planning to become pregnant. If a woman of child-bearing potential wishes to participate in this study, they will be pre-screened with a test to detect pregnancy.
Diagnosed neurogenic bladder, pudendal nerve damage, lower motor dysfunction, or other conditions that would affect the neural circuits involved in micturition.
Unwilling to allow de-identified data to be stored for future use or shared with other researchers.

Sites / Locations

University of MichiganRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Medtronic Interstim II Model 3058 Neurostimulator

Arm Description

Outcomes

Primary Outcome Measures

Evoked bladder contractions of at least 20 centimeters of water (cmH2O) during the stage-4 test

At least 50% of participants

Secondary Outcome Measures

Selectivity index for selective stimulation of pudendal nerve branches for patient stimulation

Selectivity Index (SI) will be calculated for each sensor recording from distal pudendal nerve branches. This includes sensors in the proximal urethra (proximal perineal branch - PPB), distal urethra (distal perineal branch - DPB), and anal electromyography (EMG) (ischeal rectal nerve - IRN). The SI calculation may be modified in some patients, as necessary, for factors such as the presence of a short urethra that only allows for a single intraurethral pressure measure (female urethras < male urethras) and/or the placement of EMG in the perineal floor between yields one or more additional sensors.

Selectivity index for selective stimulation of pudendal nerve branches for simulated model stimulation

Selectivity Index (SI) will be calculated for each sensor recording from distal pudendal nerve branches. This includes sensors in the proximal urethra (proximal perineal branch - PPB), distal urethra (distal perineal branch - DPB), and anal EMG (ischeal rectal nerve - IRN). The SI calculation may be modified in some patients, as necessary, for factors such as the presence of a short urethra that only allows for a single intraurethral pressure measure (female urethras < male urethras) and/or the placement of EMG in the perineal floor between yields one or more additional sensors.

Full Information

NCT ID

NCT04236596

First Posted

January 13, 2020

Last Updated

May 4, 2023

Sponsor

University of Michigan

Collaborators

National Institutes of Health (NIH)

1. Study Identification

Unique Protocol Identification Number

NCT04236596

Brief Title

Pudendal Nerve Mapping Towards Improved Neuromodulation for Urinary Retention

Official Title

Pudendal Nerve Mapping Towards Improved Neuromodulation for Urinary Retention

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 14, 2020 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

Collaborators

National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

Brief Summary

This study is to map the pudendal nerve. In this study the researchers will examine subjects who are already receiving an implanted stimulator at their pudendal nerve as part of their normal clinical care.

Detailed Description

The pudendal nerve goes to the urethra, anus, and other areas of the pelvic floor. Electrical stimulation of this nerve can help with bladder problems and pelvic pain. Researchers do not understand how the nerve anatomy is different between people. Successfully mapping the pudendal nerve may help improve the medical care for future patients with bladder problems, pelvic pain, bowel problems, and sexual problems.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Retention, Underactive Bladder

Keywords

pudendal nerve mapping

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Medtronic Interstim II Model 3058 Neurostimulator

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Medtronic Interstim II Model 3058 Neurostimulator

Intervention Description

All stimulation parameters used will be within the normal hard-coded limits of the implantable pulse generator (IPG).

Primary Outcome Measure Information:

Title

Evoked bladder contractions of at least 20 centimeters of water (cmH2O) during the stage-4 test

Description

At least 50% of participants

Time Frame

Visit 4, approximately 10 weeks after consent

Secondary Outcome Measure Information:

Title

Selectivity index for selective stimulation of pudendal nerve branches for patient stimulation

Description

Time Frame

Visit 2: Stage-1 (approximately 3 weeks after consent)

Title

Selectivity index for selective stimulation of pudendal nerve branches for simulated model stimulation

Description

Selectivity Index (SI) will be calculated for each sensor recording from distal pudendal nerve branches. This includes sensors in the proximal urethra (proximal perineal branch - PPB), distal urethra (distal perineal branch - DPB), and anal EMG (ischeal rectal nerve - IRN). The SI calculation may be modified in some patients, as necessary, for factors such as the presence of a short urethra that only allows for a single intraurethral pressure measure (female urethras < male urethras) and/or the placement of EMG in the perineal floor between yields one or more additional sensors.

Time Frame

Visit 2: Stage-1 (approximately 3 weeks after consent)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinically referred as having bladder problems that have not responded to conservative treatment. Normal clinical care includes referral to implant of Medtronic Interstim neurostimulator at the pudendal nerve. Fully eligible to receive an Interstim implant. Adult (18 or older), capable of providing own informed consent and communicating clearly with research team Capable of speaking, reading, and understanding English, as all study questionnaires are standardized assessments only available in English Capable of attending all experimental sessions (Visit 1: pre-stage-1 imaging, Visit 2: stage-1 surgery, Visit 3: CT after stage-2 surgery, Visit 3: cystometrogram test) Exclusion Implanted materials that prohibit magnetic imaging Any medical problems that prevent an individual from laying flat in an MRI or CT scanner, are are claustrophobic. Areflexive or atonic bladder Pregnant or planning to become pregnant. If a woman of child-bearing potential wishes to participate in this study, they will be pre-screened with a test to detect pregnancy. Diagnosed neurogenic bladder, pudendal nerve damage, lower motor dysfunction, or other conditions that would affect the neural circuits involved in micturition. Unwilling to allow de-identified data to be stored for future use or shared with other researchers.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mackenzie Moore, MPH

Phone

734-647-8568

mooremac@med.umich.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tim Bruns, Ph.D.

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Priyanka Gupta, M.D.

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mackenzie Moore, MPH

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

All de-identified IPD collected during the trial will be available.

IPD Sharing Time Frame

Will be available starting twelve months following publication of study findings.

IPD Sharing Access Criteria

Anyone who wishes to access the data.

IPD Sharing URL

https://sparc.science/data?type=dataset

Learn more about this trial

Pudendal Nerve Mapping Towards Improved Neuromodulation for Urinary Retention

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