Overview
This trial investigates brain and pelvic floor muscle activity in patients undergoing robot-assisted radical prostatectomy. This trial may help identify the brain waves that are associated with muscles involved in giving patients control over the bladder.
Description
PRIMARY OBJECTIVES:
- Identify pelvic floor muscle (PFM) activity on electromyogram (EMG) and electroencephalography (EEG).
- Identify any synchrony in EMG and EEG for PFM activity.
- Identify any relationship between EEG activity and UDS findings.
SECONDARY OBJECTIVES:
I. Identify changes in EEG and EMG activity with Kegel exercise. II. Examine relationship between EEG activity and continence.
EXPLORATORY OBJECTIVE:
I. Examine feasibility of replacing EMG with EEG monitoring for muscle activity.
- OUTLINE
Patients perform standard of care Kegel exercises while undergoing brain and muscle activity monitoring by EEG and EMG and UDS, respectively, before surgery, 6 weeks after surgery, 3,months after surgery and 6 months after surgery.. Patients complete questionnaires over 5-10 minutes about urinary function.
Eligibility
Inclusion Criteria:
- Adults who had or are undergoing robot-assisted radical prostatectomy (RARP)
- Must be continent preoperatively
- Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria:
- Unwilling or unable to follow protocol requirements
- Any condition which in the Investigator's opinion deems the participant an unsuitable candidate for study participation