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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

Sponsor
Larkin Health System (Other)
Overall Status
Completed
CT.gov ID
NCT05735223
Collaborator
(none)
35
Enrollment
1
Location
1
Arm
15.5
Actual Duration (Months)
2.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Maximal urethral length preservation technique of robot assisted radical prostatectomy (RALP).
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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.
Primary Purpose:
Prevention
Official Title:
A Prospective Study to Evaluate the Impact of Maximal Urethral Length Preservation Technique During Robotic Laparoscopic Prostatectomy in Terms of Continence Rates
Actual Study Start Date :
Sep 30, 2021
Actual Primary Completion Date :
Jan 15, 2023
Actual Study Completion Date :
Jan 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Stretched flaccid penile length (SFPL) following RALP.

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).

Procedure: Maximal urethral length preservation technique of robot assisted radical prostatectomy (RALP).
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.

Outcome Measures

Primary Outcome Measures

  1. Penile Length [10 days post operatively]

    Stretched Flaccid Penile Length

Secondary Outcome Measures

  1. Urinary continence [3 months and 6 months postoperatively]

    Pads used.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No

Inclusion Criteria: All men undergoing robot assisted laparoscopic radical prostatectomy (RALP).

-

Exclusion Criteria:

  1. Exposure to androgen deprivation therapy

  2. Prior treatment for prostate cancer

  3. Metastatic prostate cancer

  4. History of hypospadias or urethral reconstruction

  5. History of penile implant, intracorporal injections, intraurethral suppositories

  6. Prior pelvic surgery. -

Contacts and Locations

Locations

Site City State Country Postal Code
1 Larkin Health System Miami Florida United States 33143

Sponsors and Collaborators

  • Larkin Health System

Investigators

  • Study Chair: Sanjay Razdan, MD, MCh, Larkin Health System
  • Principal Investigator: Balaji Reddy, MD, Larkin Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Balaji Reddy, MD, Principal Investigator, Larkin Health System
ClinicalTrials.gov Identifier:
NCT05735223
Other Study ID Numbers:
  • LCH-2-092019
First Posted:
Feb 21, 2023
Last Update Posted:
Feb 21, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Erectile Dysfunction
Urinary Incontinence, Stress

Study Results

No Results Posted as of Feb 21, 2023