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OpenTrials
Completed

NCT Number: NCT05735223

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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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. -

Treatment and study plan

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.

Primary outcomes

  1. Penile Length

    Time frame: 10 days post operatively

    Stretched Flaccid Penile Length

Secondary outcomes

  1. Urinary continence

    Time frame: 3 months and 6 months postoperatively

    Pads used.

Sponsors and collaborators

Lead sponsor

Larkin Health System

Other

Registry information

Official study title

A Prospective Study to Evaluate the Impact of Maximal Urethral Length Preservation Technique During Robotic Laparoscopic Prostatectomy in Terms of Continence Rates

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 21, 2023
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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