Prostate Cancer Clinical Trial

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

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.

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Full 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.

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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

Study is for people with:

Prostate Cancer

Estimated Enrollment:

100

Study ID:

NCT04646434

Recruitment Status:

Recruiting

Sponsor:

Roswell Park Cancer Institute

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There is 1 Location for this study

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Roswell Park Cancer Institute
Buffalo New York, 14263, United States More Info
Khurshid A. Guru
Contact
716-845-4107
[email protected]
Khurshid A. Guru
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

100

Study ID:

NCT04646434

Recruitment Status:

Recruiting

Sponsor:


Roswell Park Cancer Institute

How clear is this clinincal trial information?

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