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

Clinicaltrials.gov ID: NCT04646434
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 100

Conditions

Prostate Carcinoma

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

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:

    Electroencephalography

    Description:

    Undergo EEG
  • PROCEDURE:

    Electromyography

    Description:

    Undergo EMG
  • OTHER:

    Questionnaire Administration

    Description:

    Complete questionnaire
  • PROCEDURE:

    Urodynamics (UDS)

    Description:

    Undergo UDS

Outcome Measures

Primary Outcome Measures

EEG measures obtained during urination.

Time Frame: Up to 6 months after surgery

Pelvic floor muscle (PFM) EEG measures

Time Frame: Up to 6 months

Identification of Areas of synchrony in EEG Patterns and associated Urodynamics (UDS) findings

Time Frame: UP to 6 months

Secondary Outcome Measures

EEG and EMG biofeedback

Time Frame: Up to 6 months

Improvement of continence

Time Frame: Throughout life of study up to 6 months after surgery

Timeline

  • Last Updated
    August 5, 2024
  • Start Date
    November 30, 2020
  • Today
    January 16, 2025
  • Completion Date ( Estimated )
    July 13, 2029

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