Trial Outcomes & Findings for Impact of Robot-assisted Radical Prostatectomy Technique on Short-term Continence Recovery (NCT NCT02352103)
NCT ID: NCT02352103
Last Updated: 2022-02-25
Results Overview
24-hour pad weights
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
120 participants
Primary outcome timeframe
One week after the removal of the suprapubic urinary catheter
Results posted on
2022-02-25
Participant Flow
Participant milestones
| Measure |
Control Arm
Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System
Vattikuti Urology Institute radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique
da Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.
|
Treatment Arm
Retzius sparing radical prostatectomy da Vinci Surgical System
Retzius sparing radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique
da Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
60
|
59
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Robot-assisted Radical Prostatectomy Technique on Short-term Continence Recovery
Baseline characteristics by cohort
| Measure |
Control Arm
n=60 Participants
Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System
Vattikuti Urology Institute radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique
da Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.
|
Treatment Arm
n=60 Participants
Retzius sparing radical prostatectomy da Vinci Surgical System
Retzius sparing radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique
da Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.5 years
n=5 Participants
|
61 years
n=7 Participants
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
BMI
|
28 kg/m^2
n=5 Participants
|
27.9 kg/m^2
n=7 Participants
|
28 kg/m^2
n=5 Participants
|
|
preoperative prostate specific antigen level
|
5.4 ng/ml
n=5 Participants
|
5.7 ng/ml
n=7 Participants
|
5.6 ng/ml
n=5 Participants
|
|
preoperative IPSS score
|
6.5 units on a scale
n=5 Participants
|
7 units on a scale
n=7 Participants
|
7 units on a scale
n=5 Participants
|
|
preoperative SHIM score
|
20 units on a scale
n=5 Participants
|
20 units on a scale
n=7 Participants
|
20 units on a scale
n=5 Participants
|
|
NCCN clinical risk
Low Risk
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
NCCN clinical risk
Intermediate Risk
|
45 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One week after the removal of the suprapubic urinary catheter24-hour pad weights
Outcome measures
| Measure |
Control Arm
n=60 Participants
Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System
Vattikuti Urology Institute radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique
da Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.
|
Treatment Arm
n=59 Participants
Retzius sparing radical prostatectomy da Vinci Surgical System
Retzius sparing radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique
da Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.
|
|---|---|---|
|
Urinary Continence Recovery
|
25 grams
Interval 3.0 to 133.0
|
5 grams
Interval 0.0 to 25.0
|
SECONDARY outcome
Timeframe: within 3 months from the intervention0 pad per day
Outcome measures
| Measure |
Control Arm
n=60 Participants
Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System
Vattikuti Urology Institute radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique
da Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.
|
Treatment Arm
n=60 Participants
Retzius sparing radical prostatectomy da Vinci Surgical System
Retzius sparing radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique
da Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.
|
|---|---|---|
|
Number of Participants With Urinary Continence Recovery
|
46 participants
|
35 participants
|
SECONDARY outcome
Timeframe: 1-year median follow upClavien-Dindo complications
Outcome measures
| Measure |
Control Arm
n=60 Participants
Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System
Vattikuti Urology Institute radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique
da Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.
|
Treatment Arm
n=60 Participants
Retzius sparing radical prostatectomy da Vinci Surgical System
Retzius sparing radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique
da Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.
|
|---|---|---|
|
Number of Participants With Peri and Postoperative Complications
|
7 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 1-year median follow upSHIM ranges from 0-25 with higher scores indicating better sexual function; a score of \>=22 is normal and \>=17 is considered mild ED
Outcome measures
| Measure |
Control Arm
n=60 Participants
Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System
Vattikuti Urology Institute radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique
da Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.
|
Treatment Arm
n=60 Participants
Retzius sparing radical prostatectomy da Vinci Surgical System
Retzius sparing radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique
da Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.
|
|---|---|---|
|
Number of Participants Who Regained Potency Postoperatively (as Measured by Sexual Health Inventory for Men (SHIM) Score of 17 or Greater)
|
27 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 1-year median follow upPatients without biochemical evidence of disease recurrence (i.e. postop PSA \>=0.2 ng/mL)
Outcome measures
| Measure |
Control Arm
n=60 Participants
Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System
Vattikuti Urology Institute radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique
da Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.
|
Treatment Arm
n=60 Participants
Retzius sparing radical prostatectomy da Vinci Surgical System
Retzius sparing radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique
da Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.
|
|---|---|---|
|
Number of Participants Who Had Biochemical Recurrence (Post-operative Prostate-Specific Antigen (PSA) Value >=0.2 ng/ml)
|
56 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: Within 3 months from the interventionInternational Prostatic Symptom Score (continuous score from 0-35, higher scores indicating worse urinary function)
Outcome measures
| Measure |
Control Arm
n=60 Participants
Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System
Vattikuti Urology Institute radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique
da Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.
|
Treatment Arm
n=60 Participants
Retzius sparing radical prostatectomy da Vinci Surgical System
Retzius sparing radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique
da Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.
|
|---|---|---|
|
Post-operative Urinary Function and Urinary Function-related Quality of Life
|
5.5 score on a scale
Interval 4.3 to 6.7
|
4.4 score on a scale
Interval 3.4 to 5.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 year median follow up0 pad per day
Outcome measures
| Measure |
Control Arm
n=60 Participants
Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System
Vattikuti Urology Institute radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique
da Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.
|
Treatment Arm
n=60 Participants
Retzius sparing radical prostatectomy da Vinci Surgical System
Retzius sparing radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique
da Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.
|
|---|---|---|
|
Number of Patients Who Regained Urinary Continence Postoperatively
|
53 Participants
|
58 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 year median follow upPopulation: The numbers in this analyses are different from the primary analyses as some patients were lost to follow up (by one year)
MSKCC (Memorial Sloan Kettering Cancer Center) STAR questionnaire (symptom tracking and reporting). Score ranges from 0-25, with higher scores indicating better urinary function
Outcome measures
| Measure |
Control Arm
n=48 Participants
Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System
Vattikuti Urology Institute radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique
da Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.
|
Treatment Arm
n=52 Participants
Retzius sparing radical prostatectomy da Vinci Surgical System
Retzius sparing radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique
da Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.
|
|---|---|---|
|
Post-operative Urinary Function and Urinary Function-related Quality of Life
|
20 score on a scale
Interval 16.0 to 23.0
|
20 score on a scale
Interval 17.0 to 24.0
|
Adverse Events
Control Arm
Serious events: 5 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment Arm
Serious events: 7 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control Arm
n=60 participants at risk
Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System
Vattikuti Urology Institute radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique
da Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.
|
Treatment Arm
n=60 participants at risk
Retzius sparing radical prostatectomy da Vinci Surgical System
Retzius sparing radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique
da Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphocele
|
6.7%
4/60
|
10.0%
6/60
|
|
Blood and lymphatic system disorders
Pelvic hematoma
|
0.00%
0/60
|
1.7%
1/60
|
|
Gastrointestinal disorders
Umbilical hernia
|
1.7%
1/60
|
0.00%
0/60
|
Other adverse events
| Measure |
Control Arm
n=60 participants at risk
Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System
Vattikuti Urology Institute radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique
da Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.
|
Treatment Arm
n=60 participants at risk
Retzius sparing radical prostatectomy da Vinci Surgical System
Retzius sparing radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique
da Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.
|
|---|---|---|
|
Infections and infestations
Urinary tract infection
|
1.7%
1/60
|
1.7%
1/60
|
|
Renal and urinary disorders
Acute urinary retention
|
1.7%
1/60
|
3.3%
2/60
|
|
Gastrointestinal disorders
Small Bowel obstruction
|
0.00%
0/60
|
1.7%
1/60
|
Additional Information
Deepansh Dalela, MD
Vattikuti Urology Institute, Henry Ford Hospital
Phone: 3139162600
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place