Continence and Potency Following Multi-Layer Perinatal Issue alloGraft (NCT05081232) | Clinical Trial Compass
WithdrawnNot Applicable
Continence and Potency Following Multi-Layer Perinatal Issue alloGraft
Stopped: Study will not be conducted
0Started 2024-01
Plain-language summary
The purpose of this research is to determine the effectiveness of using human Umbilical Cord (UC) allograft to help improve return to erectile function and bladder control in patients following robot-assisted radical prostatectomy (RARP).
Who can participate
Age range
30 Years – 65 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male subjects with at least age of 30 to 65
. Primary diagnosis of prostate cancer selected for surgical intervention (Radical Prostatectomy)
. Primary diagnosis of organ confined untreated prostate cancer
. Planned elective radical prostatectomy with bilateral nerve sparing technique
. Negative urinalysis within 30 days prior to date of surgery
. Patient has no erectile dysfunction (SHIM Score \< 14 ) prior to date of surgery
. Patient has the willingness to comply with instruction of the investigator
. Patient has the willingness to comply with follow-up surveys
Exclusion criteria
. High-risk cancer planned for neoadjuvant therapy, full or partial excision of neurovascular bundles
. Is unable to comply with learning and documenting penile rehabilitation, including oral 5-phosphodiesterase inhibitor use, vacuum pump therapy use, and/or injectable medications
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study
. Patients that have had prior hormonal therapy such as Lupron or oral anti-androgens
. Patients with poor urinary control at baseline requiring the use of pads for leakage
. Previous history of pelvic radiation
. Previous history of simple prostatectomy or transurethral prostate surgery
. Patients with obesity defined as BMI \> 40 kg/m2