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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-08299 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 822320 | Other Identifier | Roswell Park Cancer Institute |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive Care (brain and muscle monitoring, questionnaire) | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroencephalography | Procedure | Undergo EEG |
|
| Measure | Description | Time Frame |
|---|---|---|
| EEG measures obtained during urination. | Recordings of brain and muscle activity will be collected during urination | Up to 6 months after surgery |
| Pelvic floor muscle (PFM) EEG measures | 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. | Up to 6 months |
| Identification of Areas of synchrony in EEG Patterns and associated Urodynamics (UDS) findings | UDS data of Incontinence/continence will be monitored along with EEG recordings of brain activity during urination. | UP to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| EEG and EMG biofeedback | 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 | Up to 6 months |
| Improvement of continence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Khurshid A Guru | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Recruiting | Buffalo | New York | 14263 | United States |
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| Electromyography | Procedure | Undergo EMG |
|
|
| Questionnaire Administration | Other | Complete questionnaire |
|
| Urodynamics (UDS) | Procedure | Undergo UDS |
|
|
International Prostate Symptom score - an 8 question screening tool -with a score from 0= never experienced to 5= almost always experienced.
| Throughout life of study up to 6 months after surgery |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D058765 | Neurofeedback |
| D014563 | Urodynamics |
| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |
| D014553 | Urinary Tract Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
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