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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Catheter 16 French | Active Comparator | 16 French urinary catheter |
|
| Catheter 20 French | Active Comparator | 20 French urinary catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 16 French urinary catheter | Device | 16 French urinary catheter |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | post-op day 5-7 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Corman, MD | Virginia Mason Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Mason Medical center | Seattle | Washington | 98101 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Catheter 16 French | 16 French urinary catheter |
| FG001 | Catheter 20 French | 20 French urinary catheter |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | post-op day 5-7 |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bladder neck contracture | Renal and urinary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew Stamm | Benaroya Research Institute at Virginia Mason | 206-223-6772 | Andrew.Stamm@virginiamason.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 20, 2018 | Nov 13, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 20 French urinary catheter |
| Device |
20 French urinary catheter |
|
| 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. | 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. | 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 | 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. | 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. | 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. | 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. | Week 12 |
| Number of Participants Experiencing Bladder Neck Contracture | Number of incidence of participants experiencing bladder neck contracture. | week 12 |
| Number of Participants Experiencing Bladder Neck Contracture | Number of Incidence of participants experiencing bladder neck contracture. | 1 year |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Prior Abdominal Surgery | Count of Participants | Participants |
|
| Chronic Pain | Count of Participants | Participants |
|
| Previous Transurethral Resection of Prostate (TURP) | Count of Participants | Participants |
|
| International Prostate Symptom Score | International Prostate Symptom Score allow the urologist to better understand the severity of urinary voiding symptoms. The scale includes 7 questions with a scale range from 1-5. The overall range is 0- 35. Higher values represent a worse outcome. | Mean | Standard Deviation | score |
|
| Baseline Quality of Life | Quality of life, as perceived by the patient, is assessed using the eighth question of the International Prostate Symptom Score. This question asks "If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?" The range is from a score of 1 (delighted) to 6 (terrible) and the lower the score, the better the outcome. | Mean | Standard Deviation | Score |
|
| International Index of Erectile Function | International Index of Erectile Function (IIEF) Questionnaire is a validated, multi-dimensional, self-administered questionnaire that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. The range for each of 5 questions 1 9very low) to 5 (very high). The total score can then range from 5 to 25. The higher the score the better the outcome. | Mean | Standard Deviation | score |
|
| TNM Stage | This staging system is a standard method for the cancer care team to describe how far a cancer has spread. The TNM system is based on 5 key pieces of information:the size and extent of the primary Tumor (T category),whether the cancer has spread to nearby lymph Nodes (N Category),the absence or presence of cancer outside the prostate, or metastasis (M Category). | Count of Participants | Participants |
|
| Gleason Score | The Prostate Cancer Gleason Score score ranges from 2 to 10. To determine the score, the pathologist uses a microscope to look at the patterns of cells in the prostate tissue. The most common cell pattern is given a grade of 1 (most like normal cells) to 5 (most abnormal).The pathologist will assign one Gleason grade to the most predominant pattern in your biopsy and a second Gleason grade to the second most predominant pattern and then add the 2 numbers together. A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer. | Count of Participants | Participants |
|
| Extra Prostatic Extension | Count of Participants | Participants |
|
| Seminal Vesical Invasion | Count of Participants | Participants |
|
| Pelvic Lymph Node Dissection (PLND) | Count of Participants | Participants |
|
| weight of prostate | Mean | Standard Deviation | grams |
|
| Operative time | Mean | Standard Deviation | minutes |
|
|
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| 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. | Posted | Mean | Standard Deviation | score on a scale | week 6 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Week 6 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | week 12 |
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | tablets | after discharge until post-op day 7 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | milligrams | after discharge until post-op day 7 |
|
|
|
| Secondary | Number of Incontinence Pads Used | Patient reported number of incontinence pads used per day. The lower the number the better the outcome. | Posted | Mean | Standard Deviation | number of pads | week 6 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | number of pads | Week 12 |
|
|
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| Secondary | Number of Participants Experiencing Bladder Neck Contracture | Number of incidence of participants experiencing bladder neck contracture. | Posted | Count of Participants | Participants | week 12 |
|
|
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| Secondary | Number of Participants Experiencing Bladder Neck Contracture | Number of Incidence of participants experiencing bladder neck contracture. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | 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. | 0 | 21 | 0 | 21 | 1 | 21 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |