Urinary Incontinence
Conditions
Keywords
prostate cancer, Urinary continence, robotic assisted radical prostatectomy, Vattikuti Urology Institute (VIP) radical prostatectomy, Retzius sparing radical prostatectomy
Brief 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.
Detailed description
Traditionally, RARP is performed using a trans-peritoneal technique that pass anteriorly to the bladder. This technique necessitates the dissection and/or manipulation of many structures, which might compromise post-operative urinary continence recovery. These structures include the pubo-prostatic ligament, Santorini plexus, neurovascular bundle, and veil of Aphrodite. Recently, a Retzius-sparing technique to perform RARP has beed described. This approach passes posteriorly to the bladder, through the space of Douglas, which should minimize the damaged to the aforementioned structure. Theoretically, the latter technique should improve post-operative urinary continence recovery. However, a randomized comparison between the traditional RARP and Retzius-sparing RARP is still lacking.
Interventions
PROCEDURERetzius sparing radical prostatectomy
Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique
PROCEDUREVattikuti Urology Institute radical prostatectomy
Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique
DEVICEda 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.
Sponsors
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
40 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary Continence Recovery | One week after the removal of the suprapubic urinary catheter | 24-hour pad weights |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Urinary Function and Urinary Function-related Quality of Life | Within 3 months from the intervention | International Prostatic Symptom Score (continuous score from 0-35, higher scores indicating worse urinary function) |
| Number of Participants Who Regained Potency Postoperatively (as Measured by Sexual Health Inventory for Men (SHIM) Score of 17 or Greater) | 1-year median follow up | SHIM ranges from 0-25 with higher scores indicating better sexual function; a score of \>=22 is normal and \>=17 is considered mild ED |
| Number of Participants Who Had Biochemical Recurrence (Post-operative Prostate-Specific Antigen (PSA) Value >=0.2 ng/ml) | 1-year median follow up | Patients without biochemical evidence of disease recurrence (i.e. postop PSA \>=0.2 ng/mL) |
| Number of Participants With Urinary Continence Recovery | within 3 months from the intervention | 0 pad per day |
| Number of Participants With Peri and Postoperative Complications | 1-year median follow up | Clavien-Dindo complications |
Other
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Urinary Function and Urinary Function-related Quality of Life | 1 year median follow up | MSKCC (Memorial Sloan Kettering Cancer Center) STAR questionnaire (symptom tracking and reporting). Score ranges from 0-25, with higher scores indicating better urinary function |
| Number of Patients Who Regained Urinary Continence Postoperatively | 1 year median follow up | 0 pad per day |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 60 |
| 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. | 60 |
| Total | 120 |
Baseline characteristics
| Characteristic | Treatment Arm | Total | Control Arm |
|---|---|---|---|
| Age, Continuous | 61 years | 61 years | 61.5 years |
| BMI | 27.9 kg/m^2 | 28 kg/m^2 | 28 kg/m^2 |
| NCCN clinical risk Intermediate Risk | 46 Participants | 91 Participants | 45 Participants |
| NCCN clinical risk Low Risk | 14 Participants | 29 Participants | 15 Participants |
| preoperative IPSS score | 7 units on a scale | 7 units on a scale | 6.5 units on a scale |
| preoperative prostate specific antigen level | 5.7 ng/ml | 5.6 ng/ml | 5.4 ng/ml |
| preoperative SHIM score | 20 units on a scale | 20 units on a scale | 20 units on a scale |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 60 Participants | 120 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 |
| other Total, other adverse events | 2 / 60 | 4 / 60 |
| serious Total, serious adverse events | 5 / 60 | 7 / 60 |
Outcome results
Primary
Urinary Continence Recovery
24-hour pad weights
Time frame: One week after the removal of the suprapubic urinary catheter
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Arm | Urinary Continence Recovery | 25 grams |
| Treatment Arm | Urinary Continence Recovery | 5 grams |
Secondary
Number of Participants Who Had Biochemical Recurrence (Post-operative Prostate-Specific Antigen (PSA) Value >=0.2 ng/ml)
Patients without biochemical evidence of disease recurrence (i.e. postop PSA \>=0.2 ng/mL)
Time frame: 1-year median follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Arm | Number of Participants Who Had Biochemical Recurrence (Post-operative Prostate-Specific Antigen (PSA) Value >=0.2 ng/ml) | 56 Participants |
| Treatment Arm | Number of Participants Who Had Biochemical Recurrence (Post-operative Prostate-Specific Antigen (PSA) Value >=0.2 ng/ml) | 50 Participants |
Secondary
Number of Participants Who Regained Potency Postoperatively (as Measured by Sexual Health Inventory for Men (SHIM) Score of 17 or Greater)
SHIM ranges from 0-25 with higher scores indicating better sexual function; a score of \>=22 is normal and \>=17 is considered mild ED
Time frame: 1-year median follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Arm | Number of Participants Who Regained Potency Postoperatively (as Measured by Sexual Health Inventory for Men (SHIM) Score of 17 or Greater) | 27 Participants |
| Treatment Arm | Number of Participants Who Regained Potency Postoperatively (as Measured by Sexual Health Inventory for Men (SHIM) Score of 17 or Greater) | 26 Participants |
Secondary
Number of Participants With Peri and Postoperative Complications
Clavien-Dindo complications
Time frame: 1-year median follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Arm | Number of Participants With Peri and Postoperative Complications | 7 Participants |
| Treatment Arm | Number of Participants With Peri and Postoperative Complications | 11 Participants |
Secondary
Number of Participants With Urinary Continence Recovery
0 pad per day
Time frame: within 3 months from the intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Arm | Number of Participants With Urinary Continence Recovery | 46 participants |
| Treatment Arm | Number of Participants With Urinary Continence Recovery | 35 participants |
Secondary
Post-operative Urinary Function and Urinary Function-related Quality of Life
International Prostatic Symptom Score (continuous score from 0-35, higher scores indicating worse urinary function)
Time frame: Within 3 months from the intervention
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control Arm | Post-operative Urinary Function and Urinary Function-related Quality of Life | 5.5 score on a scale |
| Treatment Arm | Post-operative Urinary Function and Urinary Function-related Quality of Life | 4.4 score on a scale |
Other Pre-specified
Number of Patients Who Regained Urinary Continence Postoperatively
0 pad per day
Time frame: 1 year median follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Arm | Number of Patients Who Regained Urinary Continence Postoperatively | 53 Participants |
| Treatment Arm | Number of Patients Who Regained Urinary Continence Postoperatively | 58 Participants |
Other Pre-specified
Post-operative Urinary Function and Urinary Function-related Quality of Life
MSKCC (Memorial Sloan Kettering Cancer Center) STAR questionnaire (symptom tracking and reporting). Score ranges from 0-25, with higher scores indicating better urinary function
Time frame: 1 year median follow up
Population: The numbers in this analyses are different from the primary analyses as some patients were lost to follow up (by one year)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Arm | Post-operative Urinary Function and Urinary Function-related Quality of Life | 20 score on a scale |
| Treatment Arm | Post-operative Urinary Function and Urinary Function-related Quality of Life | 20 score on a scale |