A Prospective Study to Evaluate the Impact of Maximal Urethral Length Preservation Technique During Robotic Laparoscopic Prostatectomy on the Stretched Flaccid Penile Length and Continence
Primary Purpose
Prostate Adenocarcinoma, Incontinence Stress, Erectile Dysfunction Following Radical Prostatectomy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Maximal urethral length preservation technique of robot assisted radical prostatectomy (RALP).
Sponsored by
About this trial
This is an interventional prevention trial for Prostate Adenocarcinoma
Eligibility Criteria
Inclusion Criteria: All men undergoing robot assisted laparoscopic radical prostatectomy (RALP). - Exclusion Criteria: Exposure to androgen deprivation therapy Prior treatment for prostate cancer Metastatic prostate cancer History of hypospadias or urethral reconstruction History of penile implant, intracorporal injections, intraurethral suppositories Prior pelvic surgery. -
Sites / Locations
- Larkin Health System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stretched flaccid penile length (SFPL) following RALP.
Arm Description
Stretched flaccid penile length (SFPL) was measured by a single male assessor at preoperative visit, and at the time of catheter removal (10 days post-surgery).
Outcomes
Primary Outcome Measures
Penile Length
Stretched Flaccid Penile Length
Secondary Outcome Measures
Urinary continence
Pads used.
Full Information
NCT ID
NCT05735223
First Posted
February 9, 2023
Last Updated
February 17, 2023
Sponsor
Larkin Health System
1. Study Identification
Unique Protocol Identification Number
NCT05735223
Brief Title
A Prospective Study to Evaluate the Impact of Maximal Urethral Length Preservation Technique During Robotic Laparoscopic Prostatectomy on the Stretched Flaccid Penile Length and Continence
Official Title
A Prospective Study to Evaluate the Impact of Maximal Urethral Length Preservation Technique During Robotic Laparoscopic Prostatectomy in Terms of Continence Rates
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 30, 2021 (Actual)
Primary Completion Date
January 15, 2023 (Actual)
Study Completion Date
January 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Larkin Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
After robotic prostatectomy, besides erectile function and achievement of oncological control, staying dry is also a very important desire expressed frequently by the patients. This has led to the concept of trifecta achievement after robotic prostatectomies. Hence, continence preserving prostatectomies are the order of the day today. Patient acceptance to surgery is low if the continence cannot be assured preoperatively. Many techniques have been promulgated in the last two decades.
The investigators present a novel technique of maximal urethral length preservation during surgery as an effective method of continence preservation. The investigators hypothesize that maximal preservation of urethra would lead to improved and early continence after robotic prostatectomy. The investigators also hypothesize that urethral preservation spares penile length shortening. The investigators therefore propose to prospectively evaluate penile length shortening.
While penile length change after radical prostatectomy has been studied in the past, the investigators like to assess the penile morphometric assessment following the novel technique of maximal urethral length preservation radical prostatectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Adenocarcinoma, Incontinence Stress, Erectile Dysfunction Following Radical Prostatectomy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
In an IRB approved study, we prospectively evaluated the stretched flaccid penile length (SFPL) pre and post robot assisted laparoscopic radical prostatectomy (RALP) in subjects with a diagnosis of prostate cancer. The multiparametric MRI (MP-MRI) was utilized for surgical planning if available preoperatively. Repeated measures t-test, linear regression and 2-way ANOVA analyses were performed.
Masking
None (Open Label)
Masking Description
Stretched flaccid penile length (SFPL) was measured by a single male assessor at preoperative visit, and at the time of catheter removal (10 days post-surgery). The subjects were blinded to the measurements to prevent bias.
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stretched flaccid penile length (SFPL) following RALP.
Arm Type
Experimental
Arm Description
Stretched flaccid penile length (SFPL) was measured by a single male assessor at preoperative visit, and at the time of catheter removal (10 days post-surgery).
Intervention Type
Procedure
Intervention Name(s)
Maximal urethral length preservation technique of robot assisted radical prostatectomy (RALP).
Intervention Description
Stretched flaccid penile length (SFPL) was measured by a single male assessor at preoperative visit, and at the time of catheter removal (10 days post-surgery). The subjects were blinded to the measurements to prevent bias. Multiparametric MRI (MP-MRI) of the prostate were reviewed when available for surgical planning. All subjects underwent RALP with MULP using the technique previously published by Hamada et al. Continence defined as requiring no pads was assessed at 3 and 6 months postoperatively.
Primary Outcome Measure Information:
Title
Penile Length
Description
Stretched Flaccid Penile Length
Time Frame
10 days post operatively
Secondary Outcome Measure Information:
Title
Urinary continence
Description
Pads used.
Time Frame
3 months and 6 months postoperatively
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All men undergoing robot assisted laparoscopic radical prostatectomy (RALP).
-
Exclusion Criteria:
Exposure to androgen deprivation therapy
Prior treatment for prostate cancer
Metastatic prostate cancer
History of hypospadias or urethral reconstruction
History of penile implant, intracorporal injections, intraurethral suppositories
Prior pelvic surgery. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjay Razdan, MD, MCh
Organizational Affiliation
Larkin Health System
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Balaji Reddy, MD
Organizational Affiliation
Larkin Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Larkin Health System
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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A Prospective Study to Evaluate the Impact of Maximal Urethral Length Preservation Technique During Robotic Laparoscopic Prostatectomy on the Stretched Flaccid Penile Length and Continence
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