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

Roswell Park Comprehensive Cancer Center

Status: Enrolling

Conditions: Prostate Carcinoma

Treatments: Other: Questionnaire Administration; Procedure: Electroencephalography; Procedure: Electromyography; Procedure: Urodynamics (UDS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04646434

I 822320 (Other Identifier)

NCI-2020-08299 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Supportive Care (brain and muscle monitoring, questionnaire)

Experimental group

Description:

Patients perform standard of care Kegel exercises while undergoing brain and muscle activity monitoring by UDS, EEG and EMG, respectively, before surgery, 6 weeks after surgery, and at 3, and 6 months after surgery. Patients complete questionnaires over 5-10 minutes about urinary function

Treatment:

Procedure: Urodynamics (UDS)

Procedure: Electromyography

Procedure: Electroencephalography

Other: Questionnaire Administration