Novel Robotic Prostatectomy Technique for Early Urinary Continence (TRS-RALP)

Sir Mortimer B. Davis - Jewish General Hospital

Status: Completed

Conditions: Prostate Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06237114

2024-3985

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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