Erectile Dysfunction Mental and Behavioural Disorders Male erectile disorder
Conditions
Interventions
The nerves surrounding the prostate will be monitored during the prostatectomy procedure (intraoperatively). Simultaneously, a functional response will be measured with a tissue oxygenation monitor. T
Sponsors
Medtronic, Inc (USA)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Patient is a male between 18 years and 75 years of age 2. Patient was diagnosed with prostate cancer, undergoing nerve-sparing robotic radical prostatectomy 3. Patient has been informed of the nature of the study, agrees to its provisions and has provided written consent as approved by the Institutional Review Board (IRB) of the respective investigational site 4. Patient is able and willing to comply with all study requirements, including the follow-up evaluations and will return to the investigational site(s) for all required office visits 5. Patient has completed the International Index of Erectile Function (IIEF-5) questionnaire with a score of 17 or higher
Exclusion criteria
Exclusion criteria: 1. Patient has a history of erectile dysfunction associated with neurologic abnormalities 2. Patient has untreated hypertension (systolic blood pressure > 160mm Hg and/or diastolic blood pressure > 100mm Hg) 3. Patient has any penile anatomical abnormalities (e.g. penile fibrosis or Peyronie?s disease) 4. Patient has a penile or urinary sphincter implant 5. Patient has a history of prior radiation therapy to the pelvic region 6. Patient is participating in another investigational device, biologic, or drug study and has not completed the primary endpoint(s) or if there is a potential for clinical interference beyond the primary endpoint 7. Patient with prior pelvic surgery with a potential for clinical interference with the primary study endpoint
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of nerve monitoring, defined as ability to record compound nerve action potentials from the cavernous nerve during surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Feasibility of functional monitoring, defined as ability to evoke an increase in tissue oxygenation as a result of cavernous nerve stimulation during surgery. 2. Change in preoperative to postoperative erectile function, based on a patient-completed questionnaire (IIEF-5) at three months and six months. | — |
Countries
United States of America
Outcome results
None listed