Intraoperative Nerve Monitoring During Robot-assisted Laparoscopic Prostatectomy

Status unconfirmed · Not applicable

Conditions studied: Urinary Incontinence, Erectile Dysfunction

In brief

The purpose of this study is to determine whether the use of intraoperative nerve monitoring during robotic-assisted laparoscopic prostatectomy surgery improves post-surgery urinary continence and erectile function.

Key facts

Study ID

NCT02446808

Run by

ProPep Surgical, LLC

People needed

80

Starts

2015-06-01

Expected to finish

2018-12-01

Last updated by the study team

2018-04-10

Who can join

Age: 40 and older, up to 70. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Male subjects 40-70 years of age diagnosed with adenocarcinoma of the prostate;
• Subjects scheduled for robotic assisted radical prostatectomy for removal of localized prostate cancer;
• Subjects, who, in the opinion of the clinical Investigator, are able to understand this clinical investigation, cooperate with the investigational procedures and are willing to return for all the required post-treatment follow-up visits

You may not qualify if…

• Subjects with pre-operative urinary incontinence defined as use of pads or adult diapers;
• Subjects with previous pelvic or abdominal radiation therapy;
• Subjects with current or previous malignancy other than prostate or non-melanoma skin cancer;
• Subjects who have previously had a transurethral resection of the prostate (TURP) or holmium laser enucleation of the prostate (HoLEP), high intensity focused ultrasound (HIFU) or cryotherapy;
• Subjects with a prostate volume of >80mL
• Subjects with a body mass index (BMI) of ≥ 34;
• Subjects with current or suspected urinary tract or bladder infection(s);
• Subjects with reported unstable cardiovascular disease (e.g., unstable angina, myocardial infarction within past 6 months, cardiac failure or life-threatening arrhythmia, congestive heart failure) or symptomatic postural hypotension within 6 months before screening;
• Subjects with a history of diabetes;
• Subjects with drug, alcohol, or substance abuse reported within the last three years (subject reported);
• Subjects with a life expectancy less than study duration;
• Subjects with systemic autoimmune disorder;
• Subjects with any significant psychological disturbance that, in the opinion of the Investigator, could impair the consent process or ability to complete self-assessment questionnaires.
• Subjects with known sensitivity to any device or products required for the RALP surgery; and
• Subjects with any other condition that would contraindicate participation, as determined by the Investigator.

Where it is running

• Indiana University School of Medicine — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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