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Brain Activity Monitoring for Prostate Cancer Post-Surgery

N/A

Recruiting

Led By Khurshid A Guru

Research Sponsored by Roswell Park Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults who undergo robot-assisted radical prostatectomy (RARP)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is investigating whether there are certain brain waves that are associated with being able to control the bladder after a radical prostatectomy.

Who is the study for?

This trial is for adults with prostate cancer who are able to control their bladder before surgery and will undergo robot-assisted radical prostatectomy. They must understand the study's experimental nature and agree to it by signing a consent form. Those unable or unwilling to follow the study plan, or deemed unsuitable by the investigator, cannot participate.

What is being tested?

The trial studies brain activity (using EEG) and pelvic floor muscle activity (using EMG) in patients having robot-assisted surgery for prostate cancer. It aims to link specific brain waves with muscle control that affects bladder function post-surgery.

What are the potential side effects?

Since this trial involves monitoring techniques like EEG and EMG rather than drug interventions, side effects are minimal but may include discomfort from electrode placement or skin irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am an adult who will have or has had a robotic surgery for prostate cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

EEG measures obtained during urination.

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

Electroencephalography

Secondary study objectives

EEG and EMG biofeedback

Improvement of continence

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Supportive Care (brain and muscle monitoring, questionnaire)Experimental Treatment4 Interventions

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Electroencephalography

2013

N/A

~850

Electromyography

2018

N/A

~320