Retrograde Perfusion Sphinterometry and Autologous Sling to Improve Urinary Continence in Robotic Radical Prostatectomy
Intraoperative Evaluation or Retrograde Leack Point Pressure During Robot Assisted Radical Prostatectomy for Proper Autologous Suburethral Sling Tensioning to Improve Early Urinary Continence Recovery
1 other identifier
observational
50
1 country
1
Brief Summary
Urinary continence recovery remains one of the most bothersome side effect of modern radical prostate surgery and several technical modifications, especially in Robotic assisted radical prostatectomy procedures, have been reported in order to improve early urinary continence recovery. With the aim to improve the urinary continence recovery after robotic prostatectomy, we evaluate the impact of the use of a 6-branch retropubic suburethral autologous sling, created and placed during the procedure, in association with intraoperative evaluation of the retrograde leak point pressure by means of retrograde perfusion sphincterometry for proper sling tensioning.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 5, 2017
CompletedFirst Posted
Study publicly available on registry
February 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2017
CompletedFebruary 13, 2017
February 1, 2017
12 months
February 5, 2017
February 8, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Impact of radical prostatectomy and autologous suburethral placement on sphincteric apparatus and early urinary continence recovery
evaluation of sphincteric competence after prostate ablation and sling placement under urodynamic evaluation (Retrograde Leak Point Pressure in cmH2O) and recovery of urinary continence (number of pads used)
Intraoperative evaluation of sphincteric efficacy with Retrograde Leak Point Pressure evaluation - post operative recovery of urinary continence at catheter removal - 10 and 30 days after catheter removal - 6 and 12 months after surgery
Study Arms (1)
robotic radical prostatectomy patients
Patient scheduled to undergo robotic assisted radical prostatectomy
Interventions
Urodynamic evaluation during robotic radical prostatectomy
Eligibility Criteria
Patient affected by prostate cancer, scheduled to undergo robotic assisted radical prostatectomy
You may qualify if:
- Hystopathologically confirmed prostate cancer
You may not qualify if:
- Preoperative urinary incontinence
- Neurological disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Andrea Cestari
Milan, 20122, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Cestari, MD
Istituto Auxologico Italiano
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head Department of Urology
Study Record Dates
First Submitted
February 5, 2017
First Posted
February 13, 2017
Study Start
June 1, 2016
Primary Completion
May 30, 2017
Study Completion
June 30, 2017
Last Updated
February 13, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share