Underactive Bladder, Urinary Retention
Conditions
Keywords
Pudendal nerve mapping, Nerve stimulation
Brief 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.
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.
Interventions
DEVICEMedtronic 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).
Sponsors
National Institutes of Health (NIH)
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evoked Bladder Contractions of at Least 20 Centimeters of Water (cmH2O) During Cystometrogram | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Selective Stimulation of Pudendal Nerve Branches | 2 hours | 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. |
| Measurement of Effect of Selective Pudendal Nerve Stimulation (PNS) on Urethral Leak Point Pressure (ULPP) | 2 hours | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cystometrogram The bladder will be filled to different volumes and electrical stimulation will be applied to the pudendal nerve via the implanted neurostimulator. All stimulation parameters used will be within the normal hard-coded limits of the implantable pulse generator (IPG). | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Cystometrogram |
|---|---|
| Age, Continuous | 58.00 years STANDARD_DEVIATION 14.68 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cystometrogram | Evoked Bladder Contractions of at Least 20 Centimeters of Water (cmH2O) During Cystometrogram | 1 Participants |
Secondary
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
Population: No participants had selective external urethral sphincter stimulation.
Secondary
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
Population: No participants had selective external urethral sphincter stimulation.