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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04098809
• Other study ID #: IRB17-095
• Status: Completed
• Phase: N/A
• Start date: November 9, 2017
• Est. completion date: November 7, 2018

Study information

• Verified date: December 2019
• Source: Benaroya Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 7, 2018
• Est. primary completion date: November 7, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• 16 French urinary catheter
16 French urinary catheter
• 20 French urinary catheter
20 French urinary catheter

Locations

Country	Name	City	State
United States	Virginia Mason Medical center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Benaroya Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	post-op day 5-7
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.	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.	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.	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	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.	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.	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.	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.	Week 12
Secondary	Number of Participants Experiencing Bladder Neck Contracture	Number of incidence of participants experiencing bladder neck contracture.	week 12
Secondary	Number of Participants Experiencing Bladder Neck Contracture	Number of Incidence of participants experiencing bladder neck contracture.	1 year