An interventional study of Participants received a Neurostimulator, which was used to map the pudendal nerve in Urinary Retention and Underactive Bladder, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-20.
Sponsored by University of Michigan · Not applicable, Interventional, and Basic science
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.
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.
241 studies on the registry are indexed under Urinary Retention; 44 are open to participants now.
This study's enrollment of 22 is below the median of 90 across 187 interventional studies indexed under Urinary Retention.
Browse Urinary Retention studies →University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Study participants received an implanted neurostimulator at their pudendal nerve as part of normal clinical care. This was not an intervention study as clinical care was not modified based on study participation. Participants consented to undergo in the research study steps towards mapping of the pudendal nerve.
Device: Participants received a Neurostimulator, which was used to map the pudendal nerve
Participants in study received neurostimulator at their pudendal nerve as part of their normal clinical care. This neurostimulator was used to map the nerve.
Number of Participants With Evoked Bladder Contractions of at Least 20 Centimeters of Water (cmH2O) During the Stage-4 Test
The primary outcome measure in this study was an evoked bladder contraction of at least 20 centimeters of water (cmH2O) during the cystometrogram. These bladder contractions were evoked by applying nerve stimulation to the pudendal nerve through testing of the participant's implanted stimulator. Measure reflects number of participants who experienced an evoked bladder contraction of at least 20 centimeters of water during nerve stimulation.
Time frame: Visit 4, approximately 10 weeks after consent
Selectivity Index (SI) for Selective Stimulation of Pudendal Nerve Branches for Participant Stimulation
Selectivity refers to the degree in which a nerve could be stimulated without stimulating other nerves. SI was calculated for each sensor recording from locations innervated by distal pudendal nerve branches during the visit-2 implant procedure. This includes pressure sensors in the urethra innervated by the perineal nerve and anal electromyography (EMG) innervated by the ischeal rectal nerve. The SI calculation used here is on a scale of 0 to 1, with 0 indicating no response at all from the nerve. The closer the number is to 1, the more selective the nerve stimulated.
Time frame: Visit 2: Stage-1 (approximately 3 weeks after consent)
Selectivity Index (SI) for Selective Stimulation of Pudendal Nerve Branches for Simulated Model Stimulation
Selectivity is the degree to which part of a nerve could be stimulated without stimulating other nerve parts. For each participant who had successful MRI and CT images, a computational model was created to simulate electrical stimulation of axons distributed in two primary pudendal fascicles: perineal and rectal. The SI of stimulation does not indicate a positive or negative result in this outcome; rather, it shows the relative potential for activating just a single nerve fascicle. The negative/positive designation identifies the regional nerve activation, with -1 representing only perineal fascicle activation, +1 representing only rectal activation, and 0 indicating equal activation of both fascicles.
Time frame: Approximately one year and four months after consent
Measurement of Effect of Pudendal Nerve Stimulation on Urethral Leak Point Pressure During the Stage-4 Test
A secondary outcome measure was a goal to examine the effect of selective pudendal nerve stimulation on urethral leak point pressure during the cystometrogram.
Time frame: Visit 4, approximately 10 weeks after consent
| Milestone | Study Participants |
|---|---|
| Started | 22 |
| Completed | 14 |
| Not completed | 8 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Participants did not retain implant for entire trial | 3 |
| Withdrew: Participants did not receive implant at all | 4 |
The primary outcome measure in this study was an evoked bladder contraction of at least 20 centimeters of water (cmH2O) during the cystometrogram. These bladder contractions were evoked by applying nerve stimulation to the pudendal nerve through testing of the participant's implanted stimulator. Measure reflects number of participants who experienced an evoked bladder contraction of at least 20 centimeters of water during nerve stimulation.
| Participants | Participants Undergoing Cystometrogram |
|---|---|
| Number of Participants With Evoked Bladder Contractions of at Least 20 Centimeters of Water (cmH2O) During the Stage-4 Test | 0 |
Selectivity refers to the degree in which a nerve could be stimulated without stimulating other nerves. SI was calculated for each sensor recording from locations innervated by distal pudendal nerve branches during the visit-2 implant procedure. This includes pressure sensors in the urethra innervated by the perineal nerve and anal electromyography (EMG) innervated by the ischeal rectal nerve. The SI calculation used here is on a scale of 0 to 1, with 0 indicating no response at all from the nerve. The closer the number is to 1, the more selective the nerve stimulated.
| index | Participants Undergoing Stage-2 Implant Data Collection |
|---|---|
| Perineal nerve | 0.57 ± 0.29 |
| Rectal nerve | 0.90 ± 0.22 |
Selectivity is the degree to which part of a nerve could be stimulated without stimulating other nerve parts. For each participant who had successful MRI and CT images, a computational model was created to simulate electrical stimulation of axons distributed in two primary pudendal fascicles: perineal and rectal. The SI of stimulation does not indicate a positive or negative result in this outcome; rather, it shows the relative potential for activating just a single nerve fascicle. The negative/positive designation identifies the regional nerve activation, with -1 representing only perineal fascicle activation, +1 representing only rectal activation, and 0 indicating equal activation of both fascicles.
| index | Selectivity Index |
|---|---|
| Rectal dominant | 0.577 ± 0.193 |
| Perineal dominant | -0.533 ± 0.284 |
| Mixed | 0.288 ± 0.666 |
A secondary outcome measure was a goal to examine the effect of selective pudendal nerve stimulation on urethral leak point pressure during the cystometrogram.
No measurements were reported for this outcome.
Collected over Approximately 2 years and 8 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Study Participants | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Age, Continuous(years) | Study Participants |
|---|---|
| Mean | 54.37 ± 13.15 |
| Sex: Female, Male(Participants) | Study Participants |
|---|---|
| Female | 18 |
| Male | 4 |
| Ethnicity (NIH/OMB)(Participants) | Study Participants |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 20 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Study Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 21 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Study Participants |
|---|---|
| United States | 22 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — All de-identified IPD collected during the trial will be available.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Will be available starting twelve months following publication of study findings.
Access criteria: Anyone who wishes to access the data.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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