Previously Implanted Pudendal Nerve Stimulation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Previously Implanted Pudendal Nerve Stimulation

Conditions
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Urinary Retention, Underactive Bladder

Intervention / Treatment
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* Device: Medtronic Interstim II Model 3058 Neurostimulator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cystometrogram<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evoked bladder contractions of at least 20 centimeters of water (cmH2O) | At least 50% of participants | Visit 1, approximately 1 week after consent | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pudendal nerve mapping, Nerve stimulation