Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Location status: Recruiting
NCT Number: NCT04646434
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.
Interested in participating?
Request Info18 year and older
Male
Interventional
Not applicable
Buffalo, New York, 14263, United States
Location status: Recruiting
PRIMARY OBJECTIVES:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Undergo EEG
Other names: EEG, electroencephalogram
Undergo EMG
Other names: EMG
Complete questionnaire
Undergo UDS
Other names: UDS
Time frame: Up to 6 months after surgery
Recordings of brain and muscle activity will be collected during urination
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.
Time frame: UP to 6 months
UDS data of Incontinence/continence will be monitored along with EEG recordings of brain activity during urination.
Time frame: Up to 6 months
Patients will perform Kegel exercises while brain and muscle activity are monitored using a 128-channel EEG headset and up to 24 channel EMG system
Time frame: Throughout life of study up to 6 months after surgery
International Prostate Symptom score - an 8 question screening tool -with a score from 0= never experienced to 5= almost always experienced.
Roswell Park Cancer Institute
Other
Investigating the Correlation Between the Brain and Pelvic Floor Muscle Activity of Patients Who Had or Are Undergoing Robot-Assisted Radical Prostatectomy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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