Urinary RetentionNCT04236596
Pudendal Nerve Mapping Towards Improved Neuromodulation for Urinary Retention
A study testing Participants received a Neurostimulator, which was used to map the pudendal nerve in people with Urinary Retention and Underactive Bladder, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Retention, Underactive Bladder
- What is being tested?
- Participants received a Neurostimulator, which was used to map the pudendal nerve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2020to 8 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Urinary Retention, Underactive Bladder
- Being tested
- Participants received a Neurostimulator, which was used to map the pudendal nerve
- Keywords
- pudendal nerve mapping
- Medical subject headings
- Urinary Retention, Urinary Bladder, Underactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants received a Neurostimulator, which was used to map the pudendal nerveDevice
Participants in study received neurostimulator at their pudendal nerve as part of their normal clinical care. This neurostimulator was used to map the nerve.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Participants received a Neurostimulator, which was used to map the pudendal nerve |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Visit 4, approximately 10 weeks after consent
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Visit 4, approximately 10 weeks after consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start14 Sep 2020
- Primary completion8 Jun 2023
- Study completion8 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary RetentionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Timothy Bruns, University of Michigan
- Investigators
- Tim Bruns, Ph.D., Principal investigator, University of MichiganPriyanka Gupta, M.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236596
- Sponsor's protocol ID
- HUM00165005
- Other IDs
- OT2OD028191
- Status last verified
- Jul 2024
- First submitted
- 13 Jan 2020
- Last updated
- 20 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All de-identified IPD collected during the trial will be available.
Publications
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.
PubMed 39927446
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pudendal Nerve Mapping Towards Improved Neuromodulation for Urinary Retention
- ClinicalTrials.gov ID
- NCT04236596
- Acronym / sponsor ID
- HUM00165005
- Conditions
- Urinary Retention, Underactive Bladder
- Keywords
- pudendal nerve mapping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 8 Jun 2023 (actual)
- Study completion
- 8 Jun 2023 (actual)
- First posted
- 22 Jan 2020 (actual)
- Results
- Posted 20 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study participants | Experimental | Device: Participants received a Neurostimulator, which was used to map the pudendal nerveStudy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participants received a Neurostimulator, which was used to map the pudendal nerveParticipants in study received neurostimulator at their pudendal nerve as part of their normal clinical care. This neurostimulator was used to map the nerve. | Device | Study participants |
Primary outcome
Number of Participants With 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
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.
3 secondary outcomes
Selectivity Index (SI) for Selective Stimulation of Pudendal Nerve Branches for Participant Stimulation
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
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
Time frame: Visit 4, approximately 10 weeks after consent
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39927446Chen 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.
- Individual participant dataSharing planned: Yes. All de-identified IPD collected during the trial will be available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Bruns, Ph.D. principal investigator
University of Michigan
Priyanka Gupta, M.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participants received a Neurostimulator, which was used to map the pudendal nerve in people with Urinary Retention and Underactive Bladder, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04236596, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.