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

Part of paid clinical trials in Buffalo, New York.

Sponsor
Roswell Park Cancer Institute
Study ID
NCT04646434
Status
Recruiting

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Electroencephalography — PROCEDURE
    Undergo EEG
  • Electromyography — PROCEDURE
    Undergo EMG
  • Questionnaire Administration — OTHER
    Complete questionnaire
  • Urodynamics (UDS) — PROCEDURE
    Undergo UDS

Study Details

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.

Key Dates

Start date
Jul 13, 2023
Status verified
Aug 2025
Primary completion
Jul 13, 2029
Completion
Jul 13, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Supportive Care (brain and muscle monitoring, questionnaire)
    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 Measure

EEG measures obtained during urination. [ Time Frame: Up to 6 months after surgery ]

Locations (1)

FacilityCityStateZIPSite coordinators
Roswell Park Cancer InstituteBuffaloNew York14263
Khurshid A. Guru
716-845-4107
Khurshid A. Guru (PRINCIPAL_INVESTIGATOR)

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