Prostate Carcinoma
Conditions
Brief 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.
Detailed description
PRIMARY OBJECTIVES: * Identify pelvic floor muscle (PFM) activity on electromyogram (EMG) and electroencephalography (EEG). * Identify any synchrony in EMG and EEG for PFM activity. * Identify any relationship between EEG activity and UDS findings. 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.
Interventions
PROCEDUREElectroencephalography
Undergo EEG
PROCEDUREElectromyography
Undergo EMG
OTHERQuestionnaire Administration
Complete questionnaire
PROCEDUREUrodynamics (UDS)
Undergo UDS
Sponsors
Roswell Park Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EEG measures obtained during urination. | Up to 6 months after surgery | Recordings of brain and muscle activity will be collected during urination |
| Pelvic floor muscle (PFM) EEG measures | 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 | UP to 6 months | UDS data of Incontinence/continence will be monitored along with EEG recordings of brain activity during urination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EEG and EMG biofeedback | 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 |
| Improvement of continence | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKhurshid A Guru
Roswell Park Cancer Institute
Outcome results
None listed