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

Not Applicable

Completed

Conditions: Prostate Cancer

Interventions: Device: 20 French urinary catheter
Device: 16 French urinary catheter

Registration Number: NCT04098809

Lead Sponsor: Benaroya Research Institute

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 52

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Catheter 20 French	20 French urinary catheter	20 French urinary catheter
Catheter 16 French	16 French urinary catheter	16 French urinary catheter

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Urinary Symptoms	week 12	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.
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	1 year	Number of Incidence of participants experiencing bladder neck contracture.
Quality of Life Score	Week 12	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
Number of Incontinence Pads Used	week 6	Patient reported number of incontinence pads used per day. The lower the number 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.