Brain and Pelvic Floor Muscle Activity of Patients Who Had or Are Undergoing Robot-Assisted Radical Prostatectomy

Roswell Park Cancer Institute100 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

100

Conditions

Prostate Carcinoma

Interventions

ElectroencephalographyPROCEDURE

Undergo EEG

ElectromyographyPROCEDURE

Undergo EMG

Questionnaire AdministrationOTHER

Complete questionnaire

Urodynamics (UDS)

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Roswell Park Cancer Institute

Buffalo, New York, United States

RECRUITING

Outcomes

Primary Outcomes

EEG measures obtained during urination.

Recordings of brain and muscle activity will be collected during urination

Time frame: Up to 6 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.

Time frame: Up to 6 months

Identification of Areas of synchrony in EEG Patterns and associated Urodynamics (UDS) findings

UDS data of Incontinence/continence will be monitored along with EEG recordings of brain activity during urination.

Time frame: UP to 6 months

Secondary Outcomes

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

Time frame: Up to 6 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.

Time frame: Throughout life of study up to 6 months after surgery

Data from ClinicalTrials.gov

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