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 range30 Years – 65 Years
SexMALE
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
✕. 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