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

Not Applicable

Recruiting

• Conditions: Prostate Carcinoma
• Interventions: Procedure: Electroencephalography; Procedure: Electromyography; Other: Questionnaire Administration; Procedure: Urodynamics (UDS)

• Registration Number: NCT04646434
• Lead Sponsor: Roswell Park Cancer Institute

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:

* 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.

Study Timeline

• Study First Submitted: 2020-11-04
• Study First Submitted QC: 2020-11-20
• Study First Posted: 2020-11-30
• Study Start: 2023-07-13
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-05
• Primary Completion: 2029-07-13
• Study Completion: 2029-07-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive Care (brain and muscle monitoring, questionnaire)	Questionnaire Administration	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
Supportive Care (brain and muscle monitoring, questionnaire)	Electromyography	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
Supportive Care (brain and muscle monitoring, questionnaire)	Electroencephalography	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
Supportive Care (brain and muscle monitoring, questionnaire)	Urodynamics (UDS)	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

Primary Outcome Measures

Name	Time	Method
Pelvic floor muscle (PFM) EEG measures	Up to 6 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.
EEG measures obtained during urination.	Up to 6 months after surgery	Recordings of brain and muscle activity will be collected during urination
Identification of Areas of synchrony in EEG Patterns and associated Urodynamics (UDS) findings	UP to 6 months	UDS data of Incontinence/continence will be monitored along with EEG recordings of brain activity during urination.

Secondary Outcome Measures

Name	Time	Method
Improvement of continence	Throughout life of study up to 6 months after surgery	International Prostate Symptom score - an 8 question screening tool -with a score from 0= never experienced to 5= almost always experienced.
EEG and EMG biofeedback	Up to 6 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

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States