Actively Recruiting
Investigating the Correlation Between Brain and Pelvic Floor Muscle Activity in Patients Who Had or Are Undergoing Robot-Assisted Radical Prostatectomy
Led by Roswell Park Cancer Institute ยท Updated on 2025-08-05
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating brain and pelvic floor muscle activity in patients who have had or are undergoing robot-assisted radical prostatectomy for prostate carcinoma. The study aims to identify patterns of muscle activity using electromyogram (EMG) and electroencephalography (EEG), examining the relationship between brain waves and muscle control related to bladder function. The study also explores how EEG activity relates to urodynamics (UDS) findings and continence improvement. Participants perform standard Kegel exercises while undergoing monitoring with EEG, EMG, and UDS before surgery, and then again at 6 weeks, 3 months, and 6 months after surgery. They also complete questionnaires about urinary function lasting 5 to 10 minutes during these visits. The study evaluates changes in muscle and brain activity with exercise and explores the possibility of using EEG alone to monitor muscle activity. Throughout the study, participants are monitored up to 6 months following surgery with assessments including EEG during urination, pelvic floor muscle EEG, and synchrony between EEG patterns and urodynamics. Questionnaires assess urinary function, and the study tracks biofeedback and continence improvements. The total participation time includes several follow-up visits over 6 months to thoroughly evaluate brain and muscle activity and their impact on continence.
CONDITIONS
Brief Title
Brain and Pelvic Floor Muscle Activity of Patients Who Had or Are Undergoing Robot-Assisted Radical Prostatectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Unwilling or unable to follow protocol requirements
- Any condition which in the Investigator's opinion deems the participant an unsuitable candidate for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 6 months after surgery
Participants perform standard of care Kegel exercises while undergoing brain and muscle activity monitoring by EEG, EMG, and UDS, and complete questionnaires about urinary function before surgery, 6 weeks after surgery, and at 3 and 6 months after surgery.
4 visits (in-person): before surgery, 6 weeks, 3 months, and 6 months after surgery
Trial Site Locations
Total: 1 location
1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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