Brain and Pelvic Floor Muscle Activity of Patients Undergoing Robot-Assisted Radical Prostatectomy

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. Identify pelvic floor muscle (PFM) activity on electromyogram (EMG) and electroencephalography (EEG). II. Identify any synchrony in EMG and EEG for PFM activity. 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, respectively, before surgery, 6 weeks after surgery, and at 3, 6, and 12 months after surgery. Patients complete questionnaires over 5-10 minutes about urinary function.

Official Title
-----------------
Investigating the Correlation Between the Brain and Pelvic Floor Muscle Activity of Patients Undergoing Robot-Assisted Radical Prostatectomy

Conditions
-----------------
Prostate Carcinoma

Intervention / Treatment
-----------------
* Procedure: Electroencephalography
* Procedure: Electromyography
* Other: Questionnaire Administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults who undergo 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive Care (brain and muscle monitoring, questionnaire)<br>Patients perform standard of care Kegel exercises while undergoing brain and muscle activity monitoring by EEG and EMG, respectively, before surgery, 6 weeks after surgery, and at 3, 6, and 12 months after surgery. Patients complete questionnaires over 5-10 minutes about urinary function | Procedure: Electroencephalography<br>* Undergo EEG<br>* Other names: electroencephalogram;Procedure: Electromyography<br>* Undergo EMG<br>* Other names: EMG;Other: Questionnaire Administration<br>* Complete questionnaire<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG measures obtained during urination. | Recordings of brain and muscle activity will be collected during urination | Up to 12 months after surgery | 
| Pelvic floor muscle (PFM) EEG measures | Simultaneous recordings of brain activity using electrodes attached to the scalp and muscle activities of muscles of the anal sphincter with electrodes bonded to the skin. | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG and EMG biofeedback | Patients will perform Kegel exercises while brain and muscle activity are monitored using a 128-channel EEG headset and up to 24 channel EMG system | Up to 12 months | 
| Improvement of continence | International Prostate Symptom score - an 8 question screening tool -with a score from 0= never experienced to 5= almost always experienced. | Throughout life of study up to 12 months after surgery |