Prostate CarcinomaNCT04646434
Brain and Pelvic Floor Muscle Activity of Patients Who Had or Are Undergoing Robot-Assisted Radical Prostatectomy
A study testing Electroencephalography, Electromyography and Questionnaire Administration in people with Prostate Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- Electroencephalography, Electromyography and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2023to 13 Jul 2029
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unwilling or unable to follow protocol requirements
- Any condition which in the Investigator's opinion deems the participant an unsuitable candidate for study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: Investigating the Correlation Between the 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.
Read the 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:
- Identify changes in EEG and EMG activity with Kegel exercise. II. Examine relationship between EEG activity and continence.
EXPLORATORY OBJECTIVE:
- 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.
- Conditions
- Prostate Carcinoma
- Being tested
- Electroencephalography, Electromyography, Questionnaire Administration, Urodynamics (UDS)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroencephalographyProcedure or surgery
Also called EEG, electroencephalogram
Undergo EEG
ElectromyographyProcedure or surgery
Also called EMG
Undergo EMG
Questionnaire AdministrationOther
Complete questionnaire
Urodynamics (UDS)Procedure or surgery
Also called UDS
Undergo UDS
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Electroencephalography; Procedure: Electromyography; Other: Questionnaire Administration; Procedure: Urodynamics (UDS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG measures obtained during urination.
Recordings of brain and muscle activity will be collected during urination
Measured: 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.
Measured: 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.
Measured: UP to 6 months
Secondary outcomes (2)
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
Measured: Up to 6 months
Improvement of continence
International Prostate Symptom score - an 8 question screening tool -with a score from 0= never experienced to 5= almost always experienced.
Measured: Throughout life of study up to 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start13 Jul 2023
- Primary completion13 Jul 2029 (estimated)
- Study completion13 Jul 2029 (estimated)
Why it stopped: Protocol being updates and staff trained
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khurshid A Guru, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646434
- Sponsor's protocol ID
- I 822320
- Other IDs
- NCI-2020-08299, I 822320
- Status last verified
- Jul 2026
- First submitted
- 4 Nov 2020
- Last updated
- 3 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Correlation Between the Brain and Pelvic Floor Muscle Activity of Patients Who Had or Are Undergoing Robot-Assisted Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT04646434
- Acronym / sponsor ID
- I 822320
- Conditions
- Prostate Carcinoma
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Protocol being updates and staff trained
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 13 Jul 2029 (estimated)
- Study completion
- 13 Jul 2029 (estimated)
- First posted
- 30 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Identify changes in EEG and EMG activity with Kegel exercise. II. Examine relationship between EEG activity and continence.
EXPLORATORY OBJECTIVE:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (brain and muscle monitoring, questionnaire) | Experimental | Procedure: Electroencephalography, Procedure: Electromyography, Other: Questionnaire Administration, Procedure: Urodynamics (UDS)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Unwilling or unable to follow protocol requirements
- Any condition which in the Investigator's opinion deems the participant an unsuitable candidate for study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroencephalographyAlso: EEG, electroencephalogramUndergo EEG | Procedure or surgery | Supportive Care (brain and muscle monitoring, questionnaire) |
| ElectromyographyAlso: EMGUndergo EMG | Procedure or surgery | Supportive Care (brain and muscle monitoring, questionnaire) |
| Questionnaire AdministrationComplete questionnaire | Other | Supportive Care (brain and muscle monitoring, questionnaire) |
| Urodynamics (UDS)Also: UDSUndergo UDS | Procedure or surgery | Supportive Care (brain and muscle monitoring, questionnaire) |
Primary outcome
EEG measures obtained during urination.
Time frame: Up to 6 months after surgery
Recordings of brain and muscle activity will be collected during urination
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.
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.
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khurshid A Guru principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroencephalography, Electromyography and Questionnaire Administration in people with Prostate Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG measures obtained during urination. (time frame: Up to 6 months after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.