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Brain and Pelvic Floor Muscle Activity of Patients Undergoing Robot-Assisted Radical Prostatectomy

Sponsor
Roswell Park Cancer Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT04646434
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
48
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Electroencephalography
  • Procedure: Electromyography
  • Other: Questionnaire Administration
 N/A

Detailed Description

PRIMARY OBJECTIVES:

  1. Identify pelvic floor muscle (PFM) activity on electromyogram (EMG) and electroencephalography (EEG).

  2. Identify any synchrony in EMG and EEG for PFM activity.

SECONDARY OBJECTIVES:
  1. Identify changes in EEG and EMG activity with Kegel exercise. II. Examine relationship between EEG activity and continence.
EXPLORATORY OBJECTIVE:
  1. 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, respectively, before surgery, 6 weeks after surgery, and at 3, 6, and 12 months after surgery. Patients complete questionnaires over 5-10 minutes about urinary function.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Investigating the Correlation Between the Brain and Pelvic Floor Muscle Activity of Patients Undergoing Robot-Assisted Radical Prostatectomy
Actual Study Start Date :
Nov 30, 2020
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Nov 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Supportive Care (brain and muscle monitoring, questionnaire)

Patients perform standard of care Kegel exercises while undergoing brain and muscle activity monitoring by EEG and EMG, respectively, before surgery, 6 weeks after surgery, and at 3, 6, and 12 months after surgery. Patients complete questionnaires over 5-10 minutes about urinary function

Procedure: Electroencephalography
Undergo EEG
Other Names:
  • EEG
  • electroencephalogram

    • Procedure: Electromyography
    Undergo EMG
    Other Names:
  • EMG

    • Other: Questionnaire Administration
    Complete questionnaire

    Outcome Measures

    Primary Outcome Measures

    1. EEG measures obtained during urination. [Up to 12 months after surgery]

      Recordings of brain and muscle activity will be collected during urination

    2. Pelvic floor muscle (PFM) EEG measures [Up to 12 months]

      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.

    Secondary Outcome Measures

    1. EEG and EMG biofeedback [Up to 12 months]

      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

    2. Improvement of continence [Throughout life of study up to 12 months after surgery]

      International Prostate Symptom score - an 8 question screening tool -with a score from 0= never experienced to 5= almost always experienced.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Adults who undergo 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Roswell Park Cancer Institute Buffalo New York United States 14263

    Sponsors and Collaborators

    • Roswell Park Cancer Institute

    Investigators

    • Principal Investigator: Khurshid A Guru, Roswell Park Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Roswell Park Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT04646434
    Other Study ID Numbers:
    • I 822320
    • NCI-2020-08299
    • I 822320
    First Posted:
    Nov 30, 2020
    Last Update Posted:
    Jun 3, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Jun 3, 2022