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

NCT ID: NCT04646434Sponsor: Roswell Park Cancer InstituteLast updated: 2025-08-05

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.

Arms & interventions

  • ProcedureElectroencephalography

    Undergo EEG

  • ProcedureElectromyography

    Undergo EMG

  • OtherQuestionnaire Administration

    Complete questionnaire

  • ProcedureUrodynamics (UDS)

    Undergo UDS

Outcome measures

Primary

  • EEG measures obtained during urination.

    Recordings of brain and muscle activity will be collected during urination

    Time frame: Up to 6 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.

    Time frame: Up to 6 months

  • 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.

    Time frame: UP to 6 months

Secondary

  • EEG and EMG biofeedback

    Time frame: Up to 6 months

  • Improvement of continence

    Time frame: Throughout life of study up to 6 months after surgery

Eligibility criteria

Sex: MaleAge: 18 Years and olderHealthy volunteers: No
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 locations (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263

Recruiting
Khurshid A. Guru · Contact
716-845-4107Khurshid.Guru@roswellpark.org
Khurshid A. Guru · Principal Investigator
Brain and Pelvic Floor Muscle Activity of Patients Who Had or Are Undergoing Robot-Assisted Radical Prostatectomy | Cancerify