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NCT04646434NARecruiting

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

Roswell Park Cancer Institute

Start Date

7/13/2023

Completion Date

7/13/2029

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: * 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 Criteria

Age Range: 18 years to No maximum

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

Interventions

PROCEDURE

Electroencephalography

PROCEDURE

Electromyography

OTHER

Questionnaire Administration

PROCEDURE

Urodynamics (UDS)

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Conditions

Prostate Carcinoma

Locations

Roswell Park Cancer Institute

Buffalo, New York 14263

United States