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

NCT05735223 | Completed

• 1 other identifier: LCH-2-092019
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Adenocarcinoma; Incontinence Stress; Erectile Dysfunction Following Radical Prostatectomy

Outcome Measures

Primary Outcomes (1)

• Penile Length

  Stretched Flaccid Penile Length

  10 days post operatively

Secondary Outcomes (1)

• Urinary continence

  3 months and 6 months postoperatively

Study Arms (1)

Stretched flaccid penile length (SFPL) following RALP.

EXPERIMENTAL

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).

Interventions

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

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.

Stretched flaccid penile length (SFPL) following RALP.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Larkin Health System: lead

Study Sites (1)

Larkin Health System

Miami, Florida, 33143, United States

Location

Related Publications (22)

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MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sanjay Razdan, MD, MCh

  Larkin Health System

  STUDY CHAIR

• Balaji Reddy, MD

  Larkin Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: February 21, 2023
• Study Start: September 30, 2021
• Primary Completion: January 15, 2023
• Study Completion: January 15, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)