Trial Outcomes & Findings for Impact of Catheter Size on Peri-Operative Pain After Robotic Assisted Laparoscopic Prostatectomy (NCT NCT04098809)
NCT ID: NCT04098809
Last Updated: 2019-12-26
Results Overview
Catheter related pain was measured using a visual analog score rating mean post-operative pain on a scale from 1 (no pain) to 10 (worst possible pain). The lower the score the better the outcome.
COMPLETED
NA
52 participants
post-op day 5-7
2019-12-26
Participant Flow
Participant milestones
| Measure |
Catheter 16 French
16 French urinary catheter
|
Catheter 20 French
20 French urinary catheter
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
25
|
|
Overall Study
COMPLETED
|
24
|
21
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Catheter 16 French
16 French urinary catheter
|
Catheter 20 French
20 French urinary catheter
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Physician Decision
|
2
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Catheter 16 French
n=24 Participants
16 French urinary catheter
Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
|
Catheter 20 French
n=21 Participants
20 French urinary catheter
Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
weight of prostate
|
69.53 grams
STANDARD_DEVIATION 35.92 • n=24 Participants
|
54.30 grams
STANDARD_DEVIATION 14.79 • n=21 Participants
|
62.42 grams
STANDARD_DEVIATION 28.66 • n=45 Participants
|
|
Pelvic Lymph Node Dissection (PLND)
PLND - No
|
5 Participants
n=24 Participants
|
5 Participants
n=21 Participants
|
10 Participants
n=45 Participants
|
|
Operative time
|
186.4 minutes
STANDARD_DEVIATION 54.6 • n=24 Participants
|
171.4 minutes
STANDARD_DEVIATION 32.3 • n=21 Participants
|
179.4 minutes
STANDARD_DEVIATION 45.7 • n=45 Participants
|
|
Pelvic Lymph Node Dissection (PLND)
PLND -Yes
|
19 Participants
n=24 Participants
|
16 Participants
n=21 Participants
|
35 Participants
n=45 Participants
|
|
Age, Continuous
|
63.17 years
STANDARD_DEVIATION 7.01 • n=24 Participants
|
62.57 years
STANDARD_DEVIATION 5.95 • n=21 Participants
|
62.89 years
STANDARD_DEVIATION 6.47 • n=45 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=24 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=24 Participants
|
21 Participants
n=21 Participants
|
45 Participants
n=45 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
BMI
|
27.77 kg/m^2
STANDARD_DEVIATION 3.25 • n=24 Participants
|
27.02 kg/m^2
STANDARD_DEVIATION 3.33 • n=21 Participants
|
27.42 kg/m^2
STANDARD_DEVIATION 3.27 • n=45 Participants
|
|
Prior Abdominal Surgery
Prior Abdominal Surgery - No
|
14 Participants
n=24 Participants
|
17 Participants
n=21 Participants
|
31 Participants
n=45 Participants
|
|
Prior Abdominal Surgery
Prior Abdominal Surgery - Yes
|
10 Participants
n=24 Participants
|
4 Participants
n=21 Participants
|
14 Participants
n=45 Participants
|
|
Chronic Pain
Chronic Pain - No
|
23 Participants
n=24 Participants
|
20 Participants
n=21 Participants
|
43 Participants
n=45 Participants
|
|
Chronic Pain
Chronic Pain - Yes
|
1 Participants
n=24 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=45 Participants
|
|
Previous Transurethral Resection of Prostate (TURP)
Previous TURP - No
|
23 Participants
n=24 Participants
|
21 Participants
n=21 Participants
|
44 Participants
n=45 Participants
|
|
Previous Transurethral Resection of Prostate (TURP)
Previous TURP -Yes
|
1 Participants
n=24 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=45 Participants
|
|
International Prostate Symptom Score
|
9.24 score
STANDARD_DEVIATION 6.09 • n=24 Participants
|
10.00 score
STANDARD_DEVIATION 5.78 • n=21 Participants
|
9.59 score
STANDARD_DEVIATION 5.88 • n=45 Participants
|
|
Baseline Quality of Life
|
1.65 Score
STANDARD_DEVIATION 1.27 • n=24 Participants
|
2.11 Score
STANDARD_DEVIATION 1.18 • n=21 Participants
|
1.89 Score
STANDARD_DEVIATION 1.23 • n=45 Participants
|
|
International Index of Erectile Function
|
18.85 score
STANDARD_DEVIATION 6.83 • n=24 Participants
|
17.39 score
STANDARD_DEVIATION 7.57 • n=21 Participants
|
18.16 score
STANDARD_DEVIATION 7.13 • n=45 Participants
|
|
TNM Stage
T2N0
|
6 Participants
n=24 Participants
|
4 Participants
n=21 Participants
|
10 Participants
n=45 Participants
|
|
TNM Stage
T2NX
|
5 Participants
n=24 Participants
|
6 Participants
n=21 Participants
|
11 Participants
n=45 Participants
|
|
TNM Stage
T2cN0
|
1 Participants
n=24 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=45 Participants
|
|
TNM Stage
T3aN0
|
9 Participants
n=24 Participants
|
10 Participants
n=21 Participants
|
19 Participants
n=45 Participants
|
|
TNM Stage
T3bN0
|
2 Participants
n=24 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=45 Participants
|
|
TNM Stage
T3bN1
|
1 Participants
n=24 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=45 Participants
|
|
Gleason Score
Gleason 6
|
7 Participants
n=24 Participants
|
7 Participants
n=21 Participants
|
14 Participants
n=45 Participants
|
|
Gleason Score
Gleason 7
|
17 Participants
n=24 Participants
|
13 Participants
n=21 Participants
|
30 Participants
n=45 Participants
|
|
Gleason Score
Gleason 8
|
0 Participants
n=24 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=45 Participants
|
|
Extra Prostatic Extension
Extra Prostatic Extension - No
|
12 Participants
n=24 Participants
|
11 Participants
n=21 Participants
|
23 Participants
n=45 Participants
|
|
Extra Prostatic Extension
Extra Prostatic Extension - Yes
|
12 Participants
n=24 Participants
|
10 Participants
n=21 Participants
|
22 Participants
n=45 Participants
|
|
Seminal Vesical Invasion
Seminal Vesical Invasion - No
|
21 Participants
n=24 Participants
|
21 Participants
n=21 Participants
|
42 Participants
n=45 Participants
|
|
Seminal Vesical Invasion
Seminal Vesical Invasion -Yes
|
3 Participants
n=24 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=45 Participants
|
PRIMARY outcome
Timeframe: post-op day 5-7Catheter related pain was measured using a visual analog score rating mean post-operative pain on a scale from 1 (no pain) to 10 (worst possible pain). The lower the score the better the outcome.
Outcome measures
| Measure |
Catheter 16 French
n=24 Participants
16 French urinary catheter
Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
|
Catheter 20 French
n=21 Participants
20 French urinary catheter
Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
|
|---|---|---|
|
Catheter Related Pain: Visual Analog Score Rating
|
2.67 score on a scale
Standard Deviation 1.61
|
2.67 score on a scale
Standard Deviation 1.68
|
SECONDARY outcome
Timeframe: week 6The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).The lower the score the better the outcome.
Outcome measures
| Measure |
Catheter 16 French
n=24 Participants
16 French urinary catheter
Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
|
Catheter 20 French
n=21 Participants
20 French urinary catheter
Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
|
|---|---|---|
|
Urinary Symptoms
|
9.81 score on a scale
Standard Deviation 4.25
|
7.95 score on a scale
Standard Deviation 4.04
|
SECONDARY outcome
Timeframe: Week 6Question eight of IPSS refers to the patient's perceived quality of life. The range is from delighted with a score of zero to terrible with a score of 6. The lower the score the better the outcome.
Outcome measures
| Measure |
Catheter 16 French
n=24 Participants
16 French urinary catheter
Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
|
Catheter 20 French
n=21 Participants
20 French urinary catheter
Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
|
|---|---|---|
|
Quality of Life Score
|
3 score on a scale
Standard Deviation 1.3
|
2.95 score on a scale
Standard Deviation 1.72
|
SECONDARY outcome
Timeframe: week 12The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).The lower the score the better the outcome. Question eight refers to the patient's perceived quality of life. The range is from delighted with a score of zero to terrible with a score of 6. The lower the score the better the outcome.
Outcome measures
| Measure |
Catheter 16 French
n=24 Participants
16 French urinary catheter
Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
|
Catheter 20 French
n=21 Participants
20 French urinary catheter
Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
|
|---|---|---|
|
Urinary Symptoms
|
6.52 score on a scale
Standard Deviation 4.75
|
7.59 score on a scale
Standard Deviation 4.39
|
SECONDARY outcome
Timeframe: Week 12Question eight of the International Prostate Symptom Score (IPSS) refers to the patient's perceived quality of life. The range is from delighted with a score of zero to terrible with a score of 6. The lower the score the better the outcome
Outcome measures
| Measure |
Catheter 16 French
n=24 Participants
16 French urinary catheter
Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
|
Catheter 20 French
n=21 Participants
20 French urinary catheter
Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
|
|---|---|---|
|
Quality of Life Score
|
2.24 score on a scale
Standard Deviation 1.3
|
2.29 score on a scale
Standard Deviation 1.05
|
SECONDARY outcome
Timeframe: after discharge until post-op day 7Patient reported use of the number of tablets taken from provided prescription of opioids for post-operative pain. This will be converted to a standardized morphine equivalency for comparison. The lower the value the better the outcome.
Outcome measures
| Measure |
Catheter 16 French
n=24 Participants
16 French urinary catheter
Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
|
Catheter 20 French
n=21 Participants
20 French urinary catheter
Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
|
|---|---|---|
|
Opioid Use
|
5.00 tablets
Standard Deviation 5.68
|
4.48 tablets
Standard Deviation 5.75
|
SECONDARY outcome
Timeframe: after discharge until post-op day 7Patient reported use of the number of tablets taken from provided prescription of opioids for post-operative pain. This will be converted to a standardized morphine equivalency for comparison. The lower the value the better the outcome.
Outcome measures
| Measure |
Catheter 16 French
n=24 Participants
16 French urinary catheter
Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
|
Catheter 20 French
n=21 Participants
20 French urinary catheter
Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
|
|---|---|---|
|
Home Opioid Use in Standard Morphine Equivalency
|
37.50 milligrams
Standard Deviation 42.60
|
33.57 milligrams
Standard Deviation 43.12
|
SECONDARY outcome
Timeframe: week 6Patient reported number of incontinence pads used per day. The lower the number the better the outcome.
Outcome measures
| Measure |
Catheter 16 French
n=24 Participants
16 French urinary catheter
Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
|
Catheter 20 French
n=21 Participants
20 French urinary catheter
Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
|
|---|---|---|
|
Number of Incontinence Pads Used
|
2.00 number of pads
Standard Deviation 1.50
|
1.79 number of pads
Standard Deviation 1.32
|
SECONDARY outcome
Timeframe: Week 12Patient reported number of incontinence pads used per day. The lower the number the better the outcome.
Outcome measures
| Measure |
Catheter 16 French
n=24 Participants
16 French urinary catheter
Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
|
Catheter 20 French
n=21 Participants
20 French urinary catheter
Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
|
|---|---|---|
|
Patient Reported Number of Pads Used Per Day.
|
1.17 number of pads
Standard Deviation 1.46
|
1.13 number of pads
Standard Deviation 0.96
|
SECONDARY outcome
Timeframe: week 12Number of incidence of participants experiencing bladder neck contracture.
Outcome measures
| Measure |
Catheter 16 French
n=24 Participants
16 French urinary catheter
Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
|
Catheter 20 French
n=21 Participants
20 French urinary catheter
Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
|
|---|---|---|
|
Number of Participants Experiencing Bladder Neck Contracture
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 yearNumber of Incidence of participants experiencing bladder neck contracture.
Outcome measures
| Measure |
Catheter 16 French
n=24 Participants
16 French urinary catheter
Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
|
Catheter 20 French
n=21 Participants
20 French urinary catheter
Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
|
|---|---|---|
|
Number of Participants Experiencing Bladder Neck Contracture
|
0 Participants
|
1 Participants
|
Adverse Events
Catheter 16 French
Catheter 20 French
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Catheter 16 French
n=24 participants at risk
16 French urinary catheter
Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
|
Catheter 20 French
n=21 participants at risk
20 French urinary catheter
Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
|
|---|---|---|
|
Renal and urinary disorders
bladder neck contracture
|
0.00%
0/24 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
Additional Information
Dr. Andrew Stamm
Benaroya Research Institute at Virginia Mason
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place