Brain and Pelvic Floor Muscle Activity of Patients Who Had or Are Undergoing Robot-Assisted Radical Prostatectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-13

Study Completion Date

2029-07-13

Brief Summary

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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.

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Detailed Description

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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

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Prostate Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Supportive Care (brain and muscle monitoring, questionnaire)

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

Group Type EXPERIMENTAL

Electroencephalography

Intervention Type PROCEDURE

Undergo EEG

Electromyography

Intervention Type PROCEDURE

Undergo EMG

Questionnaire Administration

Intervention Type OTHER

Complete questionnaire

Urodynamics (UDS)

Intervention Type PROCEDURE

Undergo UDS

Interventions

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Electroencephalography

Undergo EEG

Intervention Type PROCEDURE

Electromyography

Undergo EMG

Intervention Type PROCEDURE

Questionnaire Administration

Complete questionnaire

Intervention Type OTHER

Urodynamics (UDS)

Undergo UDS

Intervention Type PROCEDURE

Other Intervention Names

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EEG electroencephalogram EMG UDS

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No