Brain and Pelvic Floor Muscle Activity of Patients Who Had or Are Undergoing Robot-Assisted Radical Prostatectomy
Conditions
Prostate CarcinomaSummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Khurshid A. Guru
- 716-845-4107
- [email protected]
Principal Investigator
- Khurshid A Guru
Eligibility Criteria
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
Study Plan
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
PROCEDURE:
ElectroencephalographyDescription:
Undergo EEGPROCEDURE:
ElectromyographyDescription:
Undergo EMGOTHER:
Questionnaire AdministrationDescription:
Complete questionnairePROCEDURE:
Urodynamics (UDS)Description:
Undergo UDS
Outcome Measures
Primary Outcome Measures
EEG measures obtained during urination.
Pelvic floor muscle (PFM) EEG measures
Identification of Areas of synchrony in EEG Patterns and associated Urodynamics (UDS) findings
Secondary Outcome Measures
EEG and EMG biofeedback
Improvement of continence
Timeline
Last Updated
August 5, 2024Start Date
November 30, 2020Today
January 16, 2025Completion Date ( Estimated )
July 13, 2029
Sponsors of this trial
Lead Sponsor
Roswell Park Cancer Institute