NCT04646434

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
39mo left

Started Jul 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress47%
Jul 2023Jul 2029

First Submitted

Initial submission to the registry

November 4, 2020

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 30, 2020

Completed
2.6 years until next milestone

Study Start

First participant enrolled

July 13, 2023

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2029

Last Updated

August 5, 2025

Status Verified

August 1, 2025

Enrollment Period

6 years

First QC Date

November 4, 2020

Last Update Submit

August 4, 2025

Conditions

Prostate Carcinoma

Outcome Measures

Primary Outcomes (3)

  • EEG measures obtained during urination.

    Recordings of brain and muscle activity will be collected during urination

    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.

    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.

    UP to 6 months

Secondary Outcomes (2)

  • EEG and EMG biofeedback

    Up to 6 months

  • Improvement of continence

    Throughout life of study up to 6 months after surgery

Study Arms (1)

Supportive Care (brain and muscle monitoring, questionnaire)

EXPERIMENTAL

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

Procedure: ElectroencephalographyProcedure: ElectromyographyOther: Questionnaire AdministrationProcedure: Urodynamics (UDS)

Interventions

ElectroencephalographyPROCEDURE

Undergo EEG

Also known as: EEG, electroencephalogram
Supportive Care (brain and muscle monitoring, questionnaire)
ElectromyographyPROCEDURE

Undergo EMG

Also known as: EMG
Supportive Care (brain and muscle monitoring, questionnaire)
Questionnaire AdministrationOTHER

Complete questionnaire

Supportive Care (brain and muscle monitoring, questionnaire)
Urodynamics (UDS)PROCEDURE

Undergo UDS

Also known as: UDS
Supportive Care (brain and muscle monitoring, questionnaire)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Unwilling or unable to follow protocol requirements
  • Any condition which in the Investigator's opinion deems the participant an unsuitable candidate for study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

NeurofeedbackUrodynamics

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, PsychologicalUrinary Tract Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Khurshid A Guru

    Roswell Park Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2020

First Posted

November 30, 2020

Study Start

July 13, 2023

Primary Completion (Estimated)

July 13, 2029

Study Completion (Estimated)

July 13, 2029

Last Updated

August 5, 2025

Record last verified: 2025-08

Locations

US(1)