NCT04646434 · Roswell Park Cancer Institute
Brain and Pelvic Floor Muscle Activity of Patients Who Had or Are Undergoing Robot-Assisted Radical Prostatectomy
What this study is 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.
View original scientific description
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.
Interventions
PROCEDURE
Electroencephalography
Undergo EEG
PROCEDURE
Electromyography
Undergo EMG
OTHER
Questionnaire Administration
Complete questionnaire
PROCEDURE
Urodynamics (UDS)
Undergo UDS
Primary outcome measures
EEG measures obtained during urination.
Time frame: Up to 6 months after surgery
Recordings of brain and muscle activity will be collected during urination
Pelvic floor muscle (PFM) EEG measures
Time frame: Up to 6 months
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.
Identification of Areas of synchrony in EEG Patterns and associated Urodynamics (UDS) findings
Time frame: UP to 6 months
UDS data of Incontinence/continence will be monitored along with EEG recordings of brain activity during urination.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Buffalo, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 5, 2025 · Source of record for eligibility and locations