Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 1:08 AM
Study NCT ID:
NCT05742334
Status:
WITHDRAWN
Last Update Posted:
2023-06-02
First Post:
2023-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating Return to Continence and Potency Following Radical Prostatectomy
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
RAP: Prospective Pilot Trial Evaluating Return to Continence and Potency Following Radical Prostatectomy Using Novel Multi-Layer Perinatal Tissue Allograft
Status:
WITHDRAWN
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The sponsor decided to not move forward with this study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| WFBCCC 85321 | OTHER | Wake Forest Baptist Comprehensive Cancer Center | View |