NCT05742334

Evaluating Return to Continence and Potency Following Radical Prostatectomy

RAP: Prospective Pilot Trial Evaluating Return to Continence and Potency Following Radical Prostatectomy Using Novel Multi-Layer Perinatal Tissue Allograft

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Male
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to determine if using human placental membrane (also called an allograft) helps to improve recovery time for erectile function and bladder control after having robot-assisted radical prostatectomy (RARP) surgery.

Detailed description

Primary Objective(s): * To evaluate the safety and feasibility of MLG-Complete™ allograft placement in patients who undergo robot-assisted radical prostatectomy (RARP) with bilateral nerve sparing. * To determine the effectiveness of using MLG-Complete™ allograft to optimize return to erectile function (potency) in patients who have had robot-assisted radical prostatectomy (RARP) with bilateral nerve sparing by utilizing the Sexual Health Inventory for Men (SHIM) score. * To determine the effectiveness of using MLG-Complete™ allograft to optimize return to continence in patients who have had robot-assisted radical prostatectomy (RARP) with bilateral nerve sparing by utilizing the American Urological Association (AUA) symptom score, assessing daily pad use from direct patient report, and by utilizing the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI Short Form). OUTLINE: Patients undergo RARP with placement of the MLG-Complete allograft on study. After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	Robot-Assisted Radical Prostatectomy with MLG-COMPLETE Allograft Implantation	The intervention will be administered on an inpatient basis. Participants receiving MLG-Complete™ will have it placed around the neurovascular bundle. Placement of the graft should not take more than 5 minutes, therefore, there should be minimal impact to overall surgical time.
DEVICE	MLG-COMPLETE Allograft Implantation	The MLG-Complete™ allograft will be placed on each neurovascular bundle (NVB) bilaterally as shown on the above picture after excision of the prostate prior to completing the urethrovesical anastomosis.

Timeline

• Start date: 2023-07-01
• Primary completion: 2024-05-01
• Completion: 2025-05-01
• First posted: 2023-02-24
• Last updated: 2023-06-02

Regulatory

• FDA-regulated device study