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

Prostate Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04646434
• Other study ID #: I 822320
• Secondary ID: NCI-2020-08299I
• Status: Recruiting
• Phase: N/A
• Start date: July 13, 2023
• Est. completion date: July 13, 2029

Study information

• Verified date: May 2024
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 13, 2029
• Est. primary completion date: July 13, 2029
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Carcinoma
• Prostatic Neoplasms

Intervention

Procedure:
• Electroencephalography
Undergo EEG
• Electromyography
Undergo EMG

Other:
• Questionnaire Administration
Complete questionnaire

Procedure:
• Urodynamics (UDS)
Undergo UDS

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG measures obtained during urination.	Recordings of brain and muscle activity will be collected during urination	Up to 6 months after surgery
Primary	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 6 months
Primary	Identification of Areas of synchrony in EEG Patterns and associated Urodynamics (UDS) findings	UDS data of Incontinence/continence will be monitored along with EEG recordings of brain activity during urination.	UP to 6 months
Secondary	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 6 months
Secondary	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 6 months after surgery