An interventional study of Medtronic Interstim II Model 3058 Neurostimulator 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 2024-06-03.
Sponsored by University of Michigan · Not applicable, Interventional, and Basic science
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.
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.
241 studies on the registry are indexed under Urinary Retention; 44 are open to participants now.
This study's enrollment of 5 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 Criteria:
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.
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.
The bladder will be filled to different volumes and electrical stimulation will be applied to the pudendal nerve via the implanted neurostimulator.
Device: Medtronic Interstim II Model 3058 Neurostimulator
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).
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.
Time frame: Visit 1, approximately 1 week after consent
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.
Time frame: 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.
Time frame: 2 hours
| Milestone | Cystometrogram |
|---|---|
| Started | 5 |
| Completed | 5 |
| Not completed | 0 |
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.
| Participants | Cystometrogram |
|---|---|
| Evoked Bladder Contractions of at Least 20 Centimeters of Water (cmH2O) During Cystometrogram | 1 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Collected over 2 years, 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cystometrogram | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Continuous(years) | Cystometrogram |
|---|---|
| Mean | 58.00 ± 14.68 |
| Sex: Female, Male(Participants) | Cystometrogram |
|---|---|
| Female | 3 |
| Male | 2 |
| Ethnicity (NIH/OMB)(Participants) | Cystometrogram |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 5 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Cystometrogram |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 4 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Cystometrogram |
|---|---|
| United States | 5 |
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 twelve months following publication of study findings, or earlier.
Access criteria: Anyone who wishes to access the data.
Data sharing details ↗ · sparc.science
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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