Trials / Recruiting
RecruitingNCT04646434
Brain and Pelvic Floor Muscle Activity of Patients Who Had or Are Undergoing Robot-Assisted Radical Prostatectomy
Investigating the Correlation Between the Brain and Pelvic Floor Muscle Activity of Patients Who Had or Are Undergoing Robot-Assisted Radical Prostatectomy
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Roswell Park Cancer Institute · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Electroencephalography | Undergo EEG |
| PROCEDURE | Electromyography | Undergo EMG |
| OTHER | Questionnaire Administration | Complete questionnaire |
| PROCEDURE | Urodynamics (UDS) | Undergo UDS |
Timeline
- Start date
- 2023-07-13
- Primary completion
- 2029-07-13
- Completion
- 2029-07-13
- First posted
- 2020-11-30
- Last updated
- 2025-08-05
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04646434. Inclusion in this directory is not an endorsement.