An interventional study of 16 French urinary catheter and 20 French urinary catheter in Prostate Cancer, sponsored by Benaroya Research Institute. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-26.
Sponsored by Benaroya Research Institute · Not applicable, Interventional, and Other
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.
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.
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This study's enrollment of 52 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
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Exclusion Criteria:
16 French urinary catheter
Device: 16 French urinary catheter
20 French urinary catheter
Device: 20 French urinary catheter
16 French urinary catheter
20 French urinary catheter
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
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
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
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
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
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
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
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
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
Number of Participants Experiencing Bladder Neck Contracture
Number of incidence of participants experiencing bladder neck contracture.
Time frame: week 12
Number of Participants Experiencing Bladder Neck Contracture
Number of Incidence of participants experiencing bladder neck contracture.
Time frame: 1 year
| Milestone | Catheter 16 French | Catheter 20 French |
|---|---|---|
| Started | 27 | 25 |
| Completed | 24 | 21 |
| Not completed | 3 | 4 |
| Withdrew: Withdrawal by subject | 1 | 3 |
| Withdrew: Physician decision | 2 | 1 |
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.
| score on a scale | Catheter 16 French | Catheter 20 French |
|---|---|---|
| Catheter Related Pain: Visual Analog Score Rating | 2.67 ± 1.61 | 2.67 ± 1.68 |
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.
| score on a scale | Catheter 16 French | Catheter 20 French |
|---|---|---|
| Urinary Symptoms | 9.81 ± 4.25 | 7.95 ± 4.04 |
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.
| score on a scale | Catheter 16 French | Catheter 20 French |
|---|---|---|
| Quality of Life Score | 3 ± 1.3 | 2.95 ± 1.72 |
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.
| score on a scale | Catheter 16 French | Catheter 20 French |
|---|---|---|
| Urinary Symptoms | 6.52 ± 4.75 | 7.59 ± 4.39 |
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
| score on a scale | Catheter 16 French | Catheter 20 French |
|---|---|---|
| Quality of Life Score | 2.24 ± 1.3 | 2.29 ± 1.05 |
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.
| tablets | Catheter 16 French | Catheter 20 French |
|---|---|---|
| Opioid Use | 5.00 ± 5.68 | 4.48 ± 5.75 |
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.
| milligrams | Catheter 16 French | Catheter 20 French |
|---|---|---|
| Home Opioid Use in Standard Morphine Equivalency | 37.50 ± 42.60 | 33.57 ± 43.12 |
Patient reported number of incontinence pads used per day. The lower the number the better the outcome.
| number of pads | Catheter 16 French | Catheter 20 French |
|---|---|---|
| Number of Incontinence Pads Used | 2.00 ± 1.50 | 1.79 ± 1.32 |
Patient reported number of incontinence pads used per day. The lower the number the better the outcome.
| number of pads | Catheter 16 French | Catheter 20 French |
|---|---|---|
| Patient Reported Number of Pads Used Per Day. | 1.17 ± 1.46 | 1.13 ± 0.96 |
Number of incidence of participants experiencing bladder neck contracture.
| Participants | Catheter 16 French | Catheter 20 French |
|---|---|---|
| Number of Participants Experiencing Bladder Neck Contracture | 0 | 0 |
Number of Incidence of participants experiencing bladder neck contracture.
| Participants | Catheter 16 French | Catheter 20 French |
|---|---|---|
| Number of Participants Experiencing Bladder Neck Contracture | 0 | 1 |
Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Catheter 16 French | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Catheter 20 French | 0/21 (0%) | 0/21 (0%) | 1/21 (4.8%) |
| Event | Catheter 16 French | Catheter 20 French |
|---|---|---|
| bladder neck contractureRenal and urinary disorders | 0/24 | 1/21 |
| Age, Continuous(years) | Catheter 16 French | Catheter 20 French | Total |
|---|---|---|---|
| Mean | 63.17 ± 7.01 | 62.57 ± 5.95 | 62.89 ± 6.47 |
| Sex: Female, Male(Participants) | Catheter 16 French | Catheter 20 French | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 24 | 21 | 45 |
| Race and Ethnicity Not Collected(Participants) | Catheter 16 French | Catheter 20 French | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| BMI(kg/m^2) | Catheter 16 French | Catheter 20 French | Total |
|---|---|---|---|
| Mean | 27.77 ± 3.25 | 27.02 ± 3.33 | 27.42 ± 3.27 |
| Prior Abdominal Surgery(Participants) | Catheter 16 French | Catheter 20 French | Total |
|---|---|---|---|
| Prior Abdominal Surgery - No | 14 | 17 | 31 |
| Prior Abdominal Surgery - Yes | 10 | 4 | 14 |
| Chronic Pain(Participants) | Catheter 16 French | Catheter 20 French | Total |
|---|---|---|---|
| Chronic Pain - No | 23 | 20 | 43 |
| Chronic Pain - Yes | 1 | 1 | 2 |
| Previous Transurethral Resection of Prostate (TURP)(Participants) | Catheter 16 French | Catheter 20 French | Total |
|---|---|---|---|
| Previous TURP - No | 23 | 21 | 44 |
| Previous TURP -Yes | 1 | 0 | 1 |
| International Prostate Symptom Score(score) | Catheter 16 French | Catheter 20 French | Total |
|---|---|---|---|
| Mean | 9.24 ± 6.09 | 10.00 ± 5.78 | 9.59 ± 5.88 |
9 further baseline measures are reported on the registry.
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Benaroya Research Institute