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

Not Applicable

Completed

• Conditions: Prostate Adenocarcinoma; Incontinence Stress; Erectile Dysfunction Following Radical Prostatectomy
• Interventions: Procedure: Maximal urethral length preservation technique of robot assisted radical prostatectomy (RALP).

• Registration Number: NCT05735223
• Lead Sponsor: Larkin Health System

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-30
• Primary Completion: 2023-01-15
• Study Completion: 2023-01-15
• Status Verified: 2023-02
• Study First Submitted: 2023-02-09
• Study First Submitted QC: 2023-02-09
• Last Update Submitted: 2023-02-17
• Study First Posted: 2023-02-21
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 35

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. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stretched flaccid penile length (SFPL) following RALP.	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).

Primary Outcome Measures

Name	Time	Method
Penile Length	10 days post operatively	Stretched Flaccid Penile Length

Secondary Outcome Measures

Name	Time	Method
Urinary continence	3 months and 6 months postoperatively	Pads used.

Trial Locations

Locations (1)

Larkin Health System; 🇺🇸 Miami, Florida, United States