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Pudendal Nerve Mapping Towards Improved Neuromodulation for Urinary Retention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04236596
Recruitment Status : Not yet recruiting
First Posted : January 22, 2020
Last Update Posted : January 29, 2020
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Timothy Bruns, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Urinary Retention Underactive Bladder Device: Medtronic Interstim II Model 3058 Neurostimulator Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pudendal Nerve Mapping Towards Improved Neuromodulation for Urinary Retention
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Arm Intervention/treatment
Experimental: Medtronic Interstim II Model 3058 Neurostimulator Device: Medtronic Interstim II Model 3058 Neurostimulator
All stimulation parameters used will be within the normal hard-coded limits of the implantable pulse generator (IPG).




Primary Outcome Measures :
  1. Evoked bladder contractions of at least 20 centimeters of water (cmH2O) during the stage-4 test [ Time Frame: Visit 4, approximately 10 weeks after consent ]
    At least 50% of participants


Secondary Outcome Measures :
  1. Selectivity index for selective stimulation of pudendal nerve branches for patient stimulation [ Time Frame: Visit 2: Stage-1 (approximately 3 weeks after consent) ]

    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.


  2. Selectivity index for selective stimulation of pudendal nerve branches for simulated model stimulation [ Time Frame: Visit 2: Stage-1 (approximately 3 weeks after consent) ]

    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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT04236596


Contacts
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Contact: Vanessa Pruitt, MSW 734-763-7104 vanesspr@umich.edu

Sponsors and Collaborators
University of Michigan
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Tim Bruns, Ph.D. University of Michigan
Principal Investigator: Priyanka Gupta, M.D. University of Michigan

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Responsible Party: Timothy Bruns, Associate Professor of Biomedical Engineering, University of Michigan
ClinicalTrials.gov Identifier: NCT04236596    
Other Study ID Numbers: HUM00165005
OT2OD028191 ( U.S. NIH Grant/Contract )
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All de-identified IPD collected during the trial will be available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Will be available starting twelve months following publication of study findings.
Access Criteria: Anyone who wishes to access the data.
URL: https://data.sparc.science/#/home

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Timothy Bruns, University of Michigan:
pudendal nerve mapping
Additional relevant MeSH terms:
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Urinary Retention
Urinary Bladder, Underactive
Urination Disorders
Urologic Diseases
Urinary Bladder Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms