Urinary RetentionNCT04473469
Previously Implanted Pudendal Nerve Stimulation
A study testing Medtronic Interstim II Model 3058 Neurostimulator in people with Urinary Retention and Underactive Bladder, run by University of Michigan at 1 site in United States.
Trial summary
This study seeks to examine the response of the bladder to different pudendal nerve stimulation frequencies, by studying patients who have been previously-implanted with pudendal nerve neurostimulators. 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?
- Medtronic Interstim II Model 3058 Neurostimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2021to 2 May 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
- Previously received an implanted neurostimulator at the pudendal nerve
- Adult (18 or older), capable of providing own informed consent and communicating clearly with the research team
- Capable of speaking, reading, and understanding English, as all study questionnaires are standardized assessments only available in English.
- Capable of attending the experimental session
Who cannot join
- Pregnant or planning to become pregnant during study. If a woman of child- bearing potential wishes to participate in this study, they will be pre-screened with a test to detect pregnancy
- Currently has a urinary tract infection (UTI)
- Currently has or tested positive in the last 14 days for COVID-19, or is symptomatic for COVID-19
- 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 seeks to examine the response of the bladder to different pudendal nerve stimulation frequencies, by studying patients who have been previously-implanted with pudendal nerve neurostimulators.
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, bowel, and sexual problems, and pelvic pain. Researchers do not fully understand how the nerve helps with these functions or how the anatomy is different between people. Successful stimulation of the pudendal nerve may help improve medical care for future patients with bladder problems, pelvic pain, bowel problems, and/or sexual problems.
- Conditions
- Urinary Retention, Underactive Bladder
- Being tested
- Medtronic Interstim II Model 3058 Neurostimulator
- Keywords
- Pudendal nerve mapping, Nerve stimulation
- 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.
Medtronic Interstim II Model 3058 NeurostimulatorDevice
Patients will undergo stimulation of the pudendal nerve. All stimulation parameters used will be within the normal hard-coded limits of the implantable pulse generator (IPG).
| Study group | Role | What they receive |
|---|---|---|
| Cystometrogram | Experimental | The bladder will be filled to different volumes and electrical stimulation will be applied to the pudendal nerve via the implanted neurostimulator. Receives: Device: Medtronic Interstim II Model 3058 Neurostimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evoked Bladder Contractions of at Least 20 Centimeters of Water (cmH2O) During Cystometrogram
The results reflects the number of participants who experienced an evoked bladder contraction of at least 20 centimeters of water during stimulation of the pudendal nerve. Bladder contractions were evoked by applying nerve stimulation to the pudendal nerve through testing of the participant's implanted stimulator.
Measured: Visit 1, approximately 1 week after consent
Secondary outcomes (2)
Selective Stimulation of Pudendal Nerve Branches
Selective stimulation of pudendal nerve branches for external urethral sphincter closure determined by comparing sensor recordings from distal pudendal nerve branches.
The intention was to measure the effect of selective PNS, configured for selective external urethral sphincter stimulation on ULPP, but this selective stimulation for this nerve bundle, as described in the protocol, proved to not be feasible within the experimental sessions. Thus, no data was gathered.
Measured: 2 hours
Measurement of Effect of Selective Pudendal Nerve Stimulation (PNS) on Urethral Leak Point Pressure (ULPP)
Measurement of effect of selective PNS on ULPP using PNS configured for external urethral sphincter selectivity.
The intention was to measure the effect of selective PNS, configured for selective external urethral sphincter stimulation on ULPP, but this selective stimulation for this nerve bundle, as described in the protocol, proved to not be feasible within the experimental sessions. Thus, no data was gathered.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start19 Jan 2021
- Primary completion2 May 2023
- Study completion2 May 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.
- 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
- 5 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
- NCT04473469
- Sponsor's protocol ID
- HUM00180124
- Other IDs
- OT2OD028191
- Status last verified
- May 2024
- First submitted
- 13 Jul 2020
- Last updated
- 3 Jun 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Previously Implanted Pudendal Nerve Stimulation
- ClinicalTrials.gov ID
- NCT04473469
- Acronym / sponsor ID
- HUM00180124
- Conditions
- Urinary Retention, Underactive Bladder
- Keywords
- Pudendal nerve mapping, Nerve stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 2 May 2023 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 16 Jul 2020 (actual)
- Results
- Posted 3 Jun 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 seeks to examine the response of the bladder to different pudendal nerve stimulation frequencies, by studying patients who have been previously-implanted with pudendal nerve neurostimulators.
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, bowel, and sexual problems, and pelvic pain. Researchers do not fully understand how the nerve helps with these functions or how the anatomy is different between people. Successful stimulation of the pudendal nerve may help improve medical care for future patients with bladder problems, pelvic pain, bowel problems, and/or 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 |
|---|---|---|
| Cystometrogram | Experimental | Device: Medtronic Interstim II Model 3058 NeurostimulatorThe bladder will be filled to different volumes and electrical stimulation will be applied to the pudendal nerve via the implanted neurostimulator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Previously received an implanted neurostimulator at the pudendal nerve
- Adult (18 or older), capable of providing own informed consent and communicating clearly with the research team
- Capable of speaking, reading, and understanding English, as all study questionnaires are standardized assessments only available in English.
- Capable of attending the experimental session
Key exclusion criteria (4 listed)
- Pregnant or planning to become pregnant during study. If a woman of child- bearing potential wishes to participate in this study, they will be pre-screened with a test to detect pregnancy
- Currently has a urinary tract infection (UTI)
- Currently has or tested positive in the last 14 days for COVID-19, or is symptomatic for COVID-19
- Unwilling to allow de-identified data to be stored for future use or shared with other researchers
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 |
|---|---|---|
| Medtronic Interstim II Model 3058 NeurostimulatorPatients will undergo stimulation of the pudendal nerve. All stimulation parameters used will be within the normal hard-coded limits of the implantable pulse generator (IPG). | Device | Cystometrogram |
Primary outcome
Evoked Bladder Contractions of at Least 20 Centimeters of Water (cmH2O) During Cystometrogram
Time frame: Visit 1, approximately 1 week after consent
The results reflects the number of participants who experienced an evoked bladder contraction of at least 20 centimeters of water during stimulation of the pudendal nerve. Bladder contractions were evoked by applying nerve stimulation to the pudendal nerve through testing of the participant's implanted stimulator.
2 secondary outcomes
Selective Stimulation of Pudendal Nerve Branches
Time frame: 2 hours
Measurement of Effect of Selective Pudendal Nerve Stimulation (PNS) on Urethral Leak Point Pressure (ULPP)
Time frame: 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related Pudendal Nerve Stimulation StudyLink provided by the sponsor.
- 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 Medtronic Interstim II Model 3058 Neurostimulator 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 4 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 3 Jun 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 3 Jun 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?
Evoked Bladder Contractions of at Least 20 Centimeters of Water (cmH2O) During Cystometrogram (time frame: Visit 1, approximately 1 week after consent). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2024.