Randomised Study Assessing Urinary Continence following Robotic Radical Prostatectomy with or without an intraoperative 'RoboSling'.

Not Applicable

Recruiting

• Conditions: Prostate Cancer; Urinary Incontinence; Cancer - Prostate; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12618002058257
• Lead Sponsor: Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-21
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 120

Inclusion Criteria

To be eligible to enter the study all patients must satisfy the following criteria:
1. Adult men aged 18 years and over
2. Undergoing prostatectomy for prostate cancer at RPA hospital in Sydney, Australia
3. Clinically suitable for robotic prostatectomy
4. Cognitively able to give written informed consent for participation
5. Elective procedure

Exclusion Criteria

Patients will be excluded if they present the following exclusion criteria:
1. The patient lacks the ability to consent for themselves
2. Patient or tumour factors precluding robotic surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the impact of incorporating the RoboSling procedure with<br>robot-assisted radical prostatectomy (RARP) surgeryon early (3 months) and late (1 year) post-operative urinary continence, compared to RARP alone. This will be measures by the rate of patient reported continence defined as 0 urinary pad usage per day at 3 months and 1 year post-operatively.<br>[ 3-months and 1-year post-operative]