Investigating brain and pelvic floor muscle activity in prostate surgery patients
Investigating the Correlation Between the Brain and Pelvic Floor Muscle Activity of Patients Who Had or Are Undergoing Robot-Assisted Radical Prostatectomy
This study tests how brain and pelvic floor muscle activity change in men having robot-assisted prostate surgery to see if it affects their urinary function, especially during Kegel exercises.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Roswell Park Cancer Institute Academic / other |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT04646434 on ClinicalTrials.gov |
What this trial studies
This trial examines the brain and pelvic floor muscle activity in patients undergoing robot-assisted radical prostatectomy. It aims to identify pelvic floor muscle activity using electromyography (EMG) and electroencephalography (EEG), as well as any synchrony between these measurements. The study also explores the relationship between EEG activity and urinary function, particularly focusing on changes during Kegel exercises. Patients will be monitored before surgery and at multiple intervals post-surgery while completing questionnaires about their urinary function.
Who should consider this trial
Good fit: Ideal candidates are adults who are continent and have undergone or are scheduled for robot-assisted radical prostatectomy.
Not a fit: Patients who are not continent preoperatively or those unable to comply with the study protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of bladder control mechanisms, potentially improving recovery and continence outcomes for patients after prostate surgery.
How similar studies have performed: While the specific approach of this study may be novel, similar studies investigating pelvic floor muscle activity and its relationship with brain activity have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Buffalo, New York
- Roswell Park Cancer Institute — Buffalo, New York, United States (Recruiting)
Study contacts
- Principal investigator: Khurshid A Guru — Roswell Park Cancer Institute
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.