Novel Robotic Prostatectomy Technique for Early Urinary Continence

NCT ID: NCT06237114

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-08
• Study Completion Date: 2025-04-10

Brief Summary

The goal of this a single arm prospective study is to evaluating the 3-month return of urinary continence outcomes of patients undergoing the transvesical retzius sparing robotic radical prostatectomy (TRS-RALP) for standard of care surgical prostate removal for treatment of prostate cancer.

The main question it aims: To have patients respond to questionnaires to collect exploratory data on patient's quality of life (QoL; EuroQol-5 Dimension 5-Level [EQ-5D-5L] and prostate cancer related urinary, bowel, and sexual function questionnaires (Expanded Prostate cancer Index Composite for Clinical Practice (EPIC-CP), at their standard of care perioperative visits at baseline and at 4 weeks, 3- and 6-months post operatively.

Detailed Description

Patients undergoing robotic prostatectomy will have their surgery performed utilizing TRS-RALP technique, which is a novel combination of two previously described techniques. This technique is a recent alteration to our standard of care method of prostate removal, and comprises two halves of two previously validated techniques performed in succession. No new safety signals are anticipated, and the technique has been in use since May 2023. The purpose of this technique change is to improve the rate of return urinary continence, which early institutional experience supports. This trial protocol has been generated to formally evaluate this continence return improvement inside a statistical framework for prospective verification in our entire patient cohort.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients undergoing standard of care robotic radical prostatectomy for localized prostate cancer

Exclusion Criteria

• Patients with previous pelvic surgery
• Patients with previous pelvic radiotherapy
• Patient with previous focal therapy for prostate cancer
• Patients aged < 18 years at diagnosis
• Legally incapable patients
• Patients who are unable to receive information about the study in a language they understand
• Patients who are unable to complete questionnaires and have no companion to help complete them
• Patients undergoing a concomitant cancer surgery

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sir Mortimer B. Davis - Jewish General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Victor McPherson

MD, MSc, FRCSC, Assistant Professor Division of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jewish General Hospital

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

2024-3985

Identifier Type: -

Identifier Source: org_study_id