Intraoperative Nerve Monitoring During Robot-assisted Laparoscopic Prostatectomy

NCT02446808 | Unknown DMC

• 1 other identifier: ProPep B-016-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Incontinence; Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• Return of urinary continence following robotic-assisted laparoscopic prostatectomy

  The proportion of subjects who have urinary continence following robotic-assisted laparoscopic prostatectomy (RALP) at 6 months postoperatively.

  6 month

Secondary Outcomes (2)

• Return of erectile function following robotic-assisted laparoscopic prostatectomy

  catheter removal which typically occurs at 1 week, 1 month, 3 month, 6 month, 12 month

• Time to urinary continence

  catheter removal which typically occurs at 1 week, 1 month, 3 month, 6 month, 12 month

Study Arms (1)

Intraoperative nerve monitoring

EXPERIMENTAL

Patients for which intraoperative nerve monitoring (electromyography) is used to identify the location of somatic pelvic nerves critical to urinary continence control and erectile function in real time during robotic-assisted laparoscopic prostatectomy surgery

Device: Intraoperative nerve monitoring

Interventions

Intraoperative nerve monitoring DEVICE

Intraoperative nerve monitoring (electromyography) is used to identify the location of somatic pelvic nerves critical to urinary continence control and erectile function in real time during robotic-assisted laparoscopic prostatectomy surgery

Intraoperative nerve monitoring

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• ProPep Surgical, LLC: lead
• Indiana University School of Medicine: collaborator

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Urinary Incontinence; Erectile Dysfunction

Interventions

Intraoperative Neurophysiological Monitoring

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases, Male; Genital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Monitoring, Intraoperative; Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Neurophysiological Monitoring; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: May 18, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 10, 2018

Record last verified: 2018-04

Locations

US (1)