N/A
Completed N=5
Previously Implanted Pudendal Nerve Stimulation
Urinary Retention · Underactive Bladder
Source: ClinicalTrials.gov NCT04473469 ↗
Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcomePrimary: Evoked Bladder Contractions of at Least 20 Centimeters of Water (cmH2O) During Cystometrogram — 1 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evoked Bladder Contractions of at Least 20 Centimeters of Water (cmH2O) During Cystometrogram |
1 | — |
| SECONDARY Selective Stimulation of Pudendal Nerve Branches |
— | — |
| SECONDARY Measurement of Effect of Selective Pudendal Nerve Stimulation (PNS) on Urethral Leak Point Pressure (ULPP) |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04473469). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.