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:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT00901420
Eligibility Criteria:
Inclusion Criteria:
1. Men who have undergone radical prostatectomy, via an open or minimally invasive approach, as primary treatment for a diagnosis of prostate cancer.
2. Men who have undergone salvage prostatectomy for recurrence after first-line radiation therapy for prostate cancer.
3. Men who underwent prostatectomy at least one year prior to study entry date. Men who received perioperative (or peri-XRT) chemotherapy or hormone therapy are eligible.
Exclusion Criteria:
1. Men who underwent other primary or secondary treatments for prostate cancer--hormone therapy as only treatment, cryosurgery, adjuvant radiation after prostatectomy
2. Men with a history of neurogenic bladder, as demonstrated by previous urodynamics.
3. Men with a history of severe outlet obstruction due to longstanding benign prostatic hyperplasia. This will be demonstrated objectively by documentation in the patient's history of preoperative AUA symptom score greater than 15 or a history of urinary retention or nocturia greater than 2 episodes per night.
4. Men who underwent additional reconstructive procedures at the time of or subsequent to prostatectomy, including augmentation, urethral sling, or urinary diversion.
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT00901420
Study Brief:
Protocol Section:
NCT00901420