Impact of Catheter Size on Peri-Operative Pain After Robotic Assisted Laparoscopic Prostatectomy

Study Overview
=================
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.

Official Title
-----------------
Impact of Catheter Size on Peri-Operative Pain After Robotic Assisted Laparoscopic Prostatectomy

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Device: 16 French urinary catheter
* Device: 20 French urinary catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Catheter 16 French<br>16 French urinary catheter | Device: 16 French urinary catheter<br>* 16 French urinary catheter<br>|
| Active Comparator: Catheter 20 French<br>20 French urinary catheter | Device: 20 French urinary catheter<br>* 20 French urinary catheter<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |