Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06237114
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-01-24
Brief Title:
Novel Robotic Prostatectomy Technique for Early Urinary Continence
Sponsor:
Sir Mortimer B Davis - Jewish General Hospital
Organization:
Sir Mortimer B Davis - Jewish General Hospital
Study Overview
Official Title:
Phase II Clinical Trial to Evaluate the Early Return of Urinary Continence Utilizing a Novel Hybrid Transvesical Adapted Retzius Sparing Robotic Assisted Radical Prostatectomy Technique
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRS-RALP
Brief Summary:
The goal of this a single arm prospective study is to evaluating the 3-month return of urinary continence outcomes of patients undergoing the transvesical retzius sparing robotic radical prostatectomy TRS-RALP for standard of care surgical prostate removal for treatment of prostate cancer
The main question it aims To have patients respond to questionnaires to collect exploratory data on patients quality of life QoL EuroQol-5 Dimension 5-Level EQ-5D-5L and prostate cancer related urinary bowel and sexual function questionnaires Expanded Prostate cancer Index Composite for Clinical Practice EPIC-CP at their standard of care perioperative visits at baseline and at 4 weeks 3- and 6-months post operatively
The main question it aims To have patients respond to questionnaires to collect exploratory data on patients quality of life QoL EuroQol-5 Dimension 5-Level EQ-5D-5L and prostate cancer related urinary bowel and sexual function questionnaires Expanded Prostate cancer Index Composite for Clinical Practice EPIC-CP at their standard of care perioperative visits at baseline and at 4 weeks 3- and 6-months post operatively
Detailed Description:
Patients undergoing robotic prostatectomy will have their surgery performed utilizing TRS-RALP technique which is a novel combination of two previously described techniques This technique is a recent alteration to our standard of care method of prostate removal and comprises two halves of two previously validated techniques performed in succession No new safety signals are anticipated and the technique has been in use since May 2023 The purpose of this technique change is to improve the rate of return urinary continence which early institutional experience supports This trial protocol has been generated to formally evaluate this continence return improvement inside a statistical framework for prospective verification in our entire patient cohort
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None