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

Randomised Study Assessing Urinary Continence following Robotic Radical Prostatectomy with or without an Intraoperative Retropubic Vascularised Fascial Sling (RoboSling)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618002058257
Acronym
RoboSling
Enrollment
120
Registered
2018-12-21
Start date
2018-12-20
Completion date
2024-09-10
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purposes of this study is to assess the urinary function of men undergoing a prostatectomy with and without a 'RoboSling', which is a thin piece of the patient's abdominal lining tissue that is stitched to the pubic bone during surgery to support the bladder. Who is it for? You may be eligible for this study if you are aged at least 18 years and are undergoing a prostatectomy for prostate cancer with one of the participating surgeons involved in this study. Study details Participants in this study will be randomised (by chance) into two groups. Both groups will undergo their planed prostatectomy procedure. One group will have a standard procedure, and the other group will have a standard procedure with the creating of a ‘RoboSling’ from their abdominal lining tissue during surgery. All participants will complete a number of questionnaires at 7 timepoints over the weeks and months just prior to and following their surgery. It is intended that this study will help to improve urinary continence in men after prostatectomy surgery in the future.

Interventions

Participants in the intervention group will first complete a baseline questionnaire when they consent to the trial, and undergo pre-operative urinal functional testing by a urologist (including a perineal/pelvic floor ultrasound, uroflow test and urodynamic assessment). They will then proceed to a robotic-assisted radical prostatectomy surgery, incorporating the construction of a retropubic vascularised fascial sling (RoboSling, the 'intervention'), completed by their treating urological surgeon

Participants in the intervention group will first complete a baseline questionnaire when they consent to the trial, and undergo pre-operative urinal functional testing by a urologist (including a perineal/pelvic floor ultrasound, uroflow test and urodynamic assessment). They will then proceed to a robotic-assisted radical prostatectomy surgery, incorporating the construction of a retropubic vascularised fascial sling (RoboSling, the 'intervention'), completed by their treating urological surgeon. The RoboSling is created by dissecting a piece of peritoneum (abdominal lining tissue) off f the rear surface of the bladder, which is then brought underneath the bladder to the front, and top corners of the flap stitched upwards under tension to the pubic bone). After surgery, intervention participants will complete a series of 6 post-operative questionnaires at set follow-up timepoints up to one year post-operative when visiting their surgeon for post-operative review/management appointments, and again undergo post-operative urinal functional testing at one-year with a urologist. The control (comparator) group will undergo all these procedures except their surgery will NOT include the construction of a RoboSling.

Sponsors

Sydney Local Health District
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 19, 2026