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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Procedure: Electroencephalography; Procedure: Electromyography

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Recruiting
      • Roswell Park Cancer Institute
      • Contact: Khurshid A. Guru; Phone Number: 716-845-4107; Email: Khurshid.Guru@roswellpark.org
      • Principal Investigator: Khurshid A. Guru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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	Other: Questionnaire Administration; Complete questionnaire; Procedure: Electroencephalography; Undergo EEG; Other Names: EEG; electroencephalogram; Procedure: Electromyography; Undergo EMG; Other Names: EMG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EEG measures obtained during urination.	Recordings of brain and muscle activity will be collected during urination	Up to 12 months after surgery
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.	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 12 months
Improvement of continence	International Prostate Symptom score - an 8 question screening tool -with a score from 0= never experienced to 5= almost always experienced.	Throughout life of study up to 12 months after surgery

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2023
• Primary Completion (Estimated): July 13, 2029
• Study Completion (Estimated): July 13, 2029

Study Registration Dates

• First Submitted: November 4, 2020
• First Submitted That Met QC Criteria: November 20, 2020
• First Posted (Actual): November 30, 2020

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: I 822320 (Other Identifier: Roswell Park Cancer Institute); NCI-2020-08299 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• 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