Phase 3
N=120
Impact of Robot-assisted Radical Prostatectomy Technique on Short-term Continence Recovery
Urinary Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT02352103 ↗Enrolled (actual)
120
Serious AEs
10.0%
Results posted
Sep 2019
Primary outcome: Primary: Urinary Continence Recovery — 25; 5 grams
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Retzius sparing radical prostatectomy (Procedure); Vattikuti Urology Institute radical prostatectomy (Procedure); da Vinci Surgical System (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Male
- Sponsor
- Henry Ford Health System
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Urinary Continence Recovery |
25; 5 | — |
| SECONDARY Number of Participants With Urinary Continence Recovery |
46; 35 | — |
| SECONDARY Number of Participants With Peri and Postoperative Complications |
7; 11 | — |
| SECONDARY Number of Participants Who Regained Potency Postoperatively (as Measured by Sexual Health Inventory for Men (SHIM) Score of 17 or Greater) |
27; 26 | — |
| SECONDARY Number of Participants Who Had Biochemical Recurrence (Post-operative Prostate-Specific Antigen (PSA) Value >=0.2 ng/ml) |
56; 50 | — |
| SECONDARY Post-operative Urinary Function and Urinary Function-related Quality of Life |
20; 20 | — |
Summary
To assess and compare the short-term post-operative continence recovery rate in two cohorts of men undergoing Robot Assisted Radical Prostatectomy (RARP), each randomized to undergo RARP with Vattikuti Institute technique or Retzius sparing technique.
Eligibility Criteria
Inclusion Criteria
- All patients with newly diagnosed prostate cancer undergoing robotic-assisted radical prostatectomy at the Vattikuti Urology Institute (performed by single surgeon, MM) as the primary treatment modality
- Be able to read and speak English and be able to provide written informed consent
Exclusion Criteria
- patients with high risk prostate cancer, defined as a biopsy Gleason score ≥8 and/or a pre-operative prostate specific antigen value ≥20 ng/ml.
- evidence of clinical nodal involvement (cN1) or metastatic disease (M1)
- patients participating in a competing study
- patients with pre-operative urinary incontinence.
Data sourced from ClinicalTrials.gov (NCT02352103). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.