Urinary Retention Clinical Trial
Official title:
Pudendal Nerve Mapping Towards Improved Neuromodulation for Urinary Retention
Verified date | December 2023 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | June 8, 2023 |
Est. primary completion date | June 8, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evoked bladder contractions of at least 20 centimeters of water (cmH2O) during the stage-4 test | At least 50% of participants | Visit 4, approximately 10 weeks after consent | |
Secondary | 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. |
Visit 2: Stage-1 (approximately 3 weeks after consent) | |
Secondary | 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. |
Visit 2: Stage-1 (approximately 3 weeks after consent) |
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