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NCT Number: NCT04646434

Brain and Pelvic Floor Muscle Activity of Patients Who Had or Are 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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location status: Recruiting

Location contact

Khurshid A. Guru

CONTACT

[email protected]

716-845-4107

Khurshid A. Guru

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

electroencephalography

Procedure

Undergo EEG

Other names: EEG, electroencephalogram

Electromyography

Procedure

Undergo EMG

Other names: EMG

Questionnaire Administration

Other

Complete questionnaire

Urodynamics (UDS)

Procedure

Undergo UDS

Other names: UDS

Primary outcomes

  1. EEG measures obtained during urination.

    Time frame: Up to 6 months after surgery

    Recordings of brain and muscle activity will be collected during urination

  2. Pelvic floor muscle (PFM) EEG measures

    Time frame: 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.

  3. Identification of Areas of synchrony in EEG Patterns and associated Urodynamics (UDS) findings

    Time frame: UP to 6 months

    UDS data of Incontinence/continence will be monitored along with EEG recordings of brain activity during urination.

Secondary outcomes

  1. EEG and EMG biofeedback

    Time frame: 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

  2. Improvement of continence

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Nov 30, 2020
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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