N/A
N=22
Pudendal Nerve Mapping Towards Improved Neuromodulation for Urinary Retention
Urinary Retention · Underactive Bladder
Bottom Line
View on ClinicalTrials.gov: NCT04236596 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Number of Participants With Evoked Bladder Contractions of at Least 20 Centimeters of Water (cmH2O) During the Stage-4 Test — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Participants received a Neurostimulator, which was used to map the pudendal nerve (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Evoked Bladder Contractions of at Least 20 Centimeters of Water (cmH2O) During the Stage-4 Test |
— | — |
| SECONDARY Selectivity Index (SI) for Selective Stimulation of Pudendal Nerve Branches for Participant Stimulation |
0.57; 0.90 | — |
| SECONDARY Selectivity Index (SI) for Selective Stimulation of Pudendal Nerve Branches for Simulated Model Stimulation |
0.577; -0.533; 0.288 | — |
| SECONDARY Measurement of Effect of Pudendal Nerve Stimulation on Urethral Leak Point Pressure During the Stage-4 Test |
— | — |
Summary
This study is to map the pudendal nerve. In this study the researchers will examine subjects who are already receiving an implanted stimulator at their pudendal nerve as part of their normal clinical care.
Eligibility Criteria
Inclusion Criteria
- Clinically referred as having bladder problems that have not responded to conservative treatment. Normal clinical care includes referral to implant of Medtronic Interstim neurostimulator at the pudendal nerve. Fully eligible to receive an Interstim implant.
- Adult (18 or older), capable of providing own informed consent and communicating clearly with research team
- Capable of speaking, reading, and understanding English, as all study questionnaires are standardized assessments only available in English
- Capable of attending all experimental sessions (Visit 1: pre-stage-1 imaging, Visit 2: stage-1 surgery, Visit 3: CT after stage-2 surgery, Visit 3: cystometrogram test)
Exclusion
- Implanted materials that prohibit magnetic imaging
- Any medical problems that prevent an individual from laying flat in an MRI or CT scanner, are are claustrophobic.
- Areflexive or atonic bladder
- Pregnant or planning to become pregnant. If a woman of child-bearing potential wishes to participate in this study, they will be pre-screened with a test to detect pregnancy.
- Diagnosed neurogenic bladder, pudendal nerve damage, lower motor dysfunction, or other conditions that would affect the neural circuits involved in micturition.
- Unwilling to allow de-identified data to be stored for future use or shared with other researchers.
Data sourced from ClinicalTrials.gov (NCT04236596). 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.