Clinical trial · Interventional
Intra-operative Neuromodulation of the Pelvic Plexus
NCT03425240CI-TRIAL-00031603unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the feasibility of electrical stimulation of nerves responsible for erectile function to evoke penile erection after surgery to remove the prostate (prostatectomy).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Erectile Dysfunction | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nerve Stimulation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nerve Stimulation
- description
- Acute placement of electrodes and electrostimulation of the pelvic plexus nerves during open radical prostatectomy.
- interventionNames
- Device: Nerve Stimulation
Primary outcomes (1)
- measure
- Penile circumference increase in millimeters.
- timeFrame
- 5 minutes
- description
- Change in penile circumference \[mm\] in response to electrical stimulation of the pelvic plexus nerves measured by a penile plethysmograph.
Secondary outcomes (2)
- measure
- Anatomic location of stimulation site
- timeFrame
- 5 to 15 minutes
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Scheduled for open radical prostatectomy procedure under total anesthesia. * Age 40 to 75 years old. * Able to read and understand patient information materials and willing to sign a written informed consent. Exclusion Criteria: * Have been diagnosed with severe vasculogenic erectile dysfunction. * Have a prior history of pelvic surgery, trauma or irradiation therapy. * Have a penile prosthesis. * Have been diagnosed with neurologic diseases that may negatively impact erectile functions. * Currently having an active implantable device (such as a pacemaker). * Posses any other characteristics that, per the investigator's judgment, may increase the risk or impair data collection for the procedure/study. * Inability to provide a fully informed consent.
References
Publications (0)
Data not yet available
No reference posted for this study.