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 @ 4:51 PM
Ignite Modification Date:
2025-12-24 @ 4:51 PM
NCT ID:
NCT06076850
Eligibility Criteria:
Inclusion Criteria:
* Patients who underwent radical prostatectomy (open, laparoscopic or robotic-assisted) with nerve-sparing (unilateral or bilateral).
* Low / intermediate-risk prostate cancer
* PSA \< 20 ng/ml
* Gleason score \< 8
* Prostate cancer pathological stage \</= T2b
* Sexually active with IIEF-5 score 3 18, with or without use of erectogenic aid / PDE5i.
Exclusion Criteria:
* Tumour upstaging beyond T2b
* Neurovascular bundle tissues bilaterally in the histopathological report.
* Scheduled treatment with pelvic radiotherapy and / or androgen deprivation therapy post-RP.
* Men with ED of neuropathological, endocrine or psychogenic origin.
* Previous pelvic surgery or radiation therapy.
* Patients with uncontrolled psychiatric conditions.
* Patients with major post-operative complications that could impact safety or effectiveness of ESWT.
* Patients with heart disease - unable to take PDE5i or prohibited from sexual activity.
* Patients on anticoagulation / antiplatelets except aspirin up to 100mg daily.
* Inflammation in the shockwave area or having penile pathology such as Peyronie's disease.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT06076850
Study Brief:
Protocol Section:
NCT06076850