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| ID | Type | Description | Link |
|---|---|---|---|
| OT2OD028191 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study participants | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Participants received a Neurostimulator, which was used to map the pudendal nerve | Device | Participants in study received neurostimulator at their pudendal nerve as part of their normal clinical care. This neurostimulator was used to map the nerve. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Visit 4, approximately 10 weeks after consent |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion
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| Name | Affiliation | Role |
|---|---|---|
| Tim Bruns, Ph.D. | University of Michigan | Principal Investigator |
| Priyanka Gupta, M.D. | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39927446 | Derived | Chen PJ, Lagunas AC, Soriano V, Gupta P, Bruns TM. Perineal and Rectal Nerve Recruitment Order Varies During Pudendal Neurostimulator Implant Surgery. Neurourol Urodyn. 2025 Apr;44(4):851-859. doi: 10.1002/nau.70010. Epub 2025 Feb 10. |
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All de-identified IPD collected during the trial will be available.
Will be available starting twelve months following publication of study findings.
Anyone who wishes to access the data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Participants | Study participants are receiving an implanted neurostimulator at their pudendal nerve and consent to undergo study procedures. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Participants | Study participants received an implanted neurostimulator at their pudendal nerve and consented to participate in study activities. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Due to scheduling conflicts and participant attrition, only 10 participants completed this part of the study. All were women. | Posted | Count of Participants | Participants | Visit 4, approximately 10 weeks after consent |
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Approximately 2 years and 8 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Participants | Study participants received an implanted neurostimulator at their pudendal nerve and consented to participate in study activities. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Timothy Bruns | University of Michigan | (734) 647-8727 | bruns@umich.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 4, 2022 | May 15, 2024 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 24, 2023 | May 15, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D016055 | Urinary Retention |
| D000077295 | Urinary Bladder, Underactive |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 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. | 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. | Visit 4, approximately 10 weeks after consent |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | 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. | Data was collected from 16 participants who received the implant. | Posted | Mean | Standard Deviation | index | Visit 2: Stage-1 (approximately 3 weeks after consent) |
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| Secondary | 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. | Computational models were created for 10 participants who received the implant. The model data was segregated into three groups: participants with selectivity indices positive (>0) for all four contacts (rectal only), negative (<0) for all four contacts (perineal only), and mixed (both >0 and <0). Each group has the same potential range for SI values: -1 to +1. Values in the Outcome Measure Data Table are calculations across all lead contacts and participants per group. | Posted | Mean | Standard Deviation | index | Approximately one year and four months after consent |
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| Secondary | 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. | Selective pudendal nerve stimulation was not performed during the cystometrogram sessions due to time limitations within experimental sessions, so there is no data available. "Selectivity" could not be accomplished as it was described in the protocol for this nerve bundle. | Posted | Visit 4, approximately 10 weeks after consent |
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| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Mixed |
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