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

Primary Purpose

Prostate Carcinoma

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Electroencephalography

Electromyography

Questionnaire Administration

About this trial

This is an interventional supportive care trial for Prostate Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Roswell Park Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive Care (brain and muscle monitoring, questionnaire)

Arm Description

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

Outcomes

Primary Outcome Measures

EEG measures obtained during urination.

Recordings of brain and muscle activity will be collected during urination

Pelvic floor muscle (PFM) EEG measures

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

EEG and EMG biofeedback

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

Improvement of continence

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

Full Information

NCT ID

NCT04646434

First Posted

November 4, 2020

Last Updated

September 19, 2023

Sponsor

Roswell Park Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT04646434

Brief Title

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

Official Title

Investigating the Correlation Between the Brain and Pelvic Floor Muscle Activity of Patients Undergoing Robot-Assisted Radical Prostatectomy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 13, 2023 (Actual)

Primary Completion Date

July 13, 2029 (Anticipated)

Study Completion Date

July 13, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Roswell Park Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. 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.

Detailed Description

PRIMARY OBJECTIVES: I. Identify pelvic floor muscle (PFM) activity on electromyogram (EMG) and electroencephalography (EEG). II. Identify any synchrony in EMG and EEG for PFM activity. 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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Carcinoma

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Supportive Care (brain and muscle monitoring, questionnaire)

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Electroencephalography

Other Intervention Name(s)

EEG, electroencephalogram

Intervention Description

Undergo EEG

Intervention Type

Procedure

Intervention Name(s)

Electromyography

Other Intervention Name(s)

EMG

Intervention Description

Undergo EMG

Intervention Type

Other

Intervention Name(s)

Questionnaire Administration

Intervention Description

Complete questionnaire

Primary Outcome Measure Information:

Title

EEG measures obtained during urination.

Description

Recordings of brain and muscle activity will be collected during urination

Time Frame

Up to 12 months after surgery

Title

Pelvic floor muscle (PFM) EEG measures

Description

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.

Time Frame

Up to 12 months

Secondary Outcome Measure Information:

Title

EEG and EMG biofeedback

Description

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

Time Frame

Up to 12 months

Title

Improvement of continence

Description

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

Time Frame

Throughout life of study up to 12 months after surgery

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Khurshid A Guru

Organizational Affiliation

Roswell Park Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Roswell Park Cancer Institute

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Khurshid A. Guru

Phone

716-845-4107

Khurshid.Guru@roswellpark.org

First Name & Middle Initial & Last Name & Degree

Khurshid A. Guru

12. IPD Sharing Statement

Learn more about this trial

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

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