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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

NCT05735223 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2023-02-21

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Larkin Health System

    lead OTHER

Principal Investigators

  • Sanjay Razdan, MD, MCh · Larkin Health System

  • Balaji Reddy, MD · Larkin Health System

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2023-01-15
Completion
2023-01-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05735223 on ClinicalTrials.gov