Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT01718704
Eligibility Criteria:
Inclusion Criteria:
* Patients with biopsy proven low/moderate risk prostate cancer (Gleason 3+3=6, 3+4=7, 3+2=5, 2+3=5, cT1c, cT2a, cT2b, preoperative prostatic specific antigen (PSA) less than 10)
* between ages 40-70
* preoperative IIEF (erectile function domain) score equal or greater than 20
* IPSS less than 10 and no urinary incontinence
Exclusion Criteria:
* Men with neurological disease
* IIEF score less than 20
* high risk prostate cancer (Gleason 4+3=7, 4+4=8, any Gleason 5, cT2c, cT3, PSA \> 10)
* spinal cord injury
* history of transurethral resection of prostate (TURP) or other prostate ablative procedures
* history of priapism, pelvic neuropathy, penile skin lesions/ulcers
* inability to understand and demonstrate device use instructions.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT01718704
Study Brief:
Protocol Section:
NCT01718704