- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04236596
Pudendal Nerve Mapping Towards Improved Neuromodulation for Urinary Retention
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mackenzie Moore, MPH
- Phone Number: 734-647-8568
- Email: mooremac@med.umich.edu
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Medtronic Interstim II Model 3058 Neurostimulator
|
All stimulation parameters used will be within the normal hard-coded limits of the implantable pulse generator (IPG).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Visit 4, approximately 10 weeks after consent
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Visit 2: Stage-1 (approximately 3 weeks after consent)
|
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. |
Visit 2: Stage-1 (approximately 3 weeks after consent)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Tim Bruns, Ph.D., University of Michigan
- Principal Investigator: Priyanka Gupta, M.D., University of Michigan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00165005
- OT2OD028191 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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