Prostate Cancer
Conditions
Brief summary
This study is designed to assess the effect of catheter size on postoperative catheter pain, urinary continence, urinary flow rates, post void residuals, International Prostate Symptom Scores (IPSS), and Quality of Life (QoL) score, as well as long term complications after robotic assisted laparoscopic prostatectomy.
Detailed description
Subjects identified to receive a robotic assisted laparoscopic prostatectomy.were randomized to either a 16 French or 20 French catheter at the completion of the prostatectomy. All prostatectomies were performed by one of three surgeons at the investigator's institution. Preoperative demographics and operative data were recorded for each group. Catheters remained in place for 7-14 days. Subjects were asked on postoperative day 7 to report their catheter-related pain and amount of opioid medication used. Urinary symptoms and quality of life scores and pads per day were recorded at 6 weeks and 12 weeks post-operatively.
Interventions
DEVICE16 French urinary catheter
16 French urinary catheter
DEVICE20 French urinary catheter
20 French urinary catheter
Sponsors
Benaroya Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Identified as candidate for robotic assisted laparoscopic prostatectomy
Exclusion criteria
* Having filled a prescription for opioid medication in last 2 months. * Known latex allergy * Known pre-operatively that catheter placement will exceed 14 days * History of pelvic radiation * Significant deviation from normal operative protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Catheter Related Pain: Visual Analog Score Rating | post-op day 5-7 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Score | Week 6 | Question 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. |
| Opioid Use | after discharge until post-op day 7 | Patient 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. |
| Home Opioid Use in Standard Morphine Equivalency | after discharge until post-op day 7 | Patient 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. |
| Urinary Symptoms | week 6 | The 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. |
| Patient Reported Number of Pads Used Per Day. | Week 12 | Patient reported number of incontinence pads used per day. The lower the number the better the outcome. |
| Number of Participants Experiencing Bladder Neck Contracture | week 12 | Number of incidence of participants experiencing bladder neck contracture. |
| Number of Incontinence Pads Used | week 6 | Patient reported number of incontinence pads used per day. The lower the number the better the outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Catheter 16 French 16 French urinary catheter
Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio. | 24 |
| Catheter 20 French 20 French urinary catheter
Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio. | 21 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 2 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Catheter 20 French | Total | Catheter 16 French |
|---|---|---|---|
| Age, Continuous | 62.57 years STANDARD_DEVIATION 5.95 | 62.89 years STANDARD_DEVIATION 6.47 | 63.17 years STANDARD_DEVIATION 7.01 |
| Baseline Quality of Life | 2.11 Score STANDARD_DEVIATION 1.18 | 1.89 Score STANDARD_DEVIATION 1.23 | 1.65 Score STANDARD_DEVIATION 1.27 |
| BMI | 27.02 kg/m^2 STANDARD_DEVIATION 3.33 | 27.42 kg/m^2 STANDARD_DEVIATION 3.27 | 27.77 kg/m^2 STANDARD_DEVIATION 3.25 |
| Chronic Pain Chronic Pain - No | 20 Participants | 43 Participants | 23 Participants |
| Chronic Pain Chronic Pain - Yes | 1 Participants | 2 Participants | 1 Participants |
| Extra Prostatic Extension Extra Prostatic Extension - No | 11 Participants | 23 Participants | 12 Participants |
| Extra Prostatic Extension Extra Prostatic Extension - Yes | 10 Participants | 22 Participants | 12 Participants |
| Gleason Score Gleason 6 | 7 Participants | 14 Participants | 7 Participants |
| Gleason Score Gleason 7 | 13 Participants | 30 Participants | 17 Participants |
| Gleason Score Gleason 8 | 1 Participants | 1 Participants | 0 Participants |
| International Index of Erectile Function | 17.39 score STANDARD_DEVIATION 7.57 | 18.16 score STANDARD_DEVIATION 7.13 | 18.85 score STANDARD_DEVIATION 6.83 |
| International Prostate Symptom Score | 10.00 score STANDARD_DEVIATION 5.78 | 9.59 score STANDARD_DEVIATION 5.88 | 9.24 score STANDARD_DEVIATION 6.09 |
| Operative time | 171.4 minutes STANDARD_DEVIATION 32.3 | 179.4 minutes STANDARD_DEVIATION 45.7 | 186.4 minutes STANDARD_DEVIATION 54.6 |
| Pelvic Lymph Node Dissection (PLND) PLND - No | 5 Participants | 10 Participants | 5 Participants |
| Pelvic Lymph Node Dissection (PLND) PLND -Yes | 16 Participants | 35 Participants | 19 Participants |
| Previous Transurethral Resection of Prostate (TURP) Previous TURP - No | 21 Participants | 44 Participants | 23 Participants |
| Previous Transurethral Resection of Prostate (TURP) Previous TURP -Yes | 0 Participants | 1 Participants | 1 Participants |
| Prior Abdominal Surgery Prior Abdominal Surgery - No | 17 Participants | 31 Participants | 14 Participants |
| Prior Abdominal Surgery Prior Abdominal Surgery - Yes | 4 Participants | 14 Participants | 10 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Seminal Vesical Invasion Seminal Vesical Invasion - No | 21 Participants | 42 Participants | 21 Participants |
| Seminal Vesical Invasion Seminal Vesical Invasion -Yes | 0 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 21 Participants | 45 Participants | 24 Participants |
| TNM Stage T2cN0 | 1 Participants | 2 Participants | 1 Participants |
| TNM Stage T2N0 | 4 Participants | 10 Participants | 6 Participants |
| TNM Stage T2NX | 6 Participants | 11 Participants | 5 Participants |
| TNM Stage T3aN0 | 10 Participants | 19 Participants | 9 Participants |
| TNM Stage T3bN0 | 0 Participants | 2 Participants | 2 Participants |
| TNM Stage T3bN1 | 0 Participants | 1 Participants | 1 Participants |
| weight of prostate | 54.30 grams STANDARD_DEVIATION 14.79 | 62.42 grams STANDARD_DEVIATION 28.66 | 69.53 grams STANDARD_DEVIATION 35.92 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 21 |
| other Total, other adverse events | 0 / 24 | 1 / 21 |
| serious Total, serious adverse events | 0 / 24 | 0 / 21 |
Outcome results
Primary
Catheter Related Pain: Visual Analog Score Rating
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.
Time frame: post-op day 5-7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Catheter 16 French | Catheter Related Pain: Visual Analog Score Rating | 2.67 score on a scale | Standard Deviation 1.61 |
| Catheter 20 French | Catheter Related Pain: Visual Analog Score Rating | 2.67 score on a scale | Standard Deviation 1.68 |
Secondary
Home Opioid Use in Standard Morphine Equivalency
Patient 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.
Time frame: after discharge until post-op day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Catheter 16 French | Home Opioid Use in Standard Morphine Equivalency | 37.50 milligrams | Standard Deviation 42.6 |
| Catheter 20 French | Home Opioid Use in Standard Morphine Equivalency | 33.57 milligrams | Standard Deviation 43.12 |
Secondary
Number of Incontinence Pads Used
Patient reported number of incontinence pads used per day. The lower the number the better the outcome.
Time frame: week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Catheter 16 French | Number of Incontinence Pads Used | 2.00 number of pads | Standard Deviation 1.5 |
| Catheter 20 French | Number of Incontinence Pads Used | 1.79 number of pads | Standard Deviation 1.32 |
Secondary
Number of Participants Experiencing Bladder Neck Contracture
Number of Incidence of participants experiencing bladder neck contracture.
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Catheter 16 French | Number of Participants Experiencing Bladder Neck Contracture | 0 Participants |
| Catheter 20 French | Number of Participants Experiencing Bladder Neck Contracture | 1 Participants |
Secondary
Number of Participants Experiencing Bladder Neck Contracture
Number of incidence of participants experiencing bladder neck contracture.
Time frame: week 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Catheter 16 French | Number of Participants Experiencing Bladder Neck Contracture | 0 Participants |
| Catheter 20 French | Number of Participants Experiencing Bladder Neck Contracture | 0 Participants |
Secondary
Opioid Use
Patient 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.
Time frame: after discharge until post-op day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Catheter 16 French | Opioid Use | 5.00 tablets | Standard Deviation 5.68 |
| Catheter 20 French | Opioid Use | 4.48 tablets | Standard Deviation 5.75 |
Secondary
Patient Reported Number of Pads Used Per Day.
Patient reported number of incontinence pads used per day. The lower the number the better the outcome.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Catheter 16 French | Patient Reported Number of Pads Used Per Day. | 1.17 number of pads | Standard Deviation 1.46 |
| Catheter 20 French | Patient Reported Number of Pads Used Per Day. | 1.13 number of pads | Standard Deviation 0.96 |
Secondary
Quality of Life Score
Question 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.
Time frame: Week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Catheter 16 French | Quality of Life Score | 3 score on a scale | Standard Deviation 1.3 |
| Catheter 20 French | Quality of Life Score | 2.95 score on a scale | Standard Deviation 1.72 |
Secondary
Quality of Life Score
Question 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
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Catheter 16 French | Quality of Life Score | 2.24 score on a scale | Standard Deviation 1.3 |
| Catheter 20 French | Quality of Life Score | 2.29 score on a scale | Standard Deviation 1.05 |
Secondary
Urinary Symptoms
The 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.
Time frame: week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Catheter 16 French | Urinary Symptoms | 6.52 score on a scale | Standard Deviation 4.75 |
| Catheter 20 French | Urinary Symptoms | 7.59 score on a scale | Standard Deviation 4.39 |
Secondary
Urinary Symptoms
The 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.
Time frame: week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Catheter 16 French | Urinary Symptoms | 9.81 score on a scale | Standard Deviation 4.25 |
| Catheter 20 French | Urinary Symptoms | 7.95 score on a scale | Standard Deviation 4.04 |