search
Back to results

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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
16 French urinary catheter
20 French urinary catheter
Sponsored by
Benaroya Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Virginia Mason Medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Catheter 16 French

Catheter 20 French

Arm Description

16 French urinary catheter

20 French urinary catheter

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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
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.
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.
Number of Incontinence Pads Used
Patient reported number of incontinence pads used per day. The lower the number the better the outcome.
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.
Number of Participants Experiencing Bladder Neck Contracture
Number of incidence of participants experiencing bladder neck contracture.
Number of Participants Experiencing Bladder Neck Contracture
Number of Incidence of participants experiencing bladder neck contracture.

Full Information

First Posted
September 11, 2019
Last Updated
December 10, 2019
Sponsor
Benaroya Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT04098809
Brief Title
Impact of Catheter Size on Peri-Operative Pain After Robotic Assisted Laparoscopic Prostatectomy
Official Title
Impact of Catheter Size on Peri-Operative Pain After Robotic Assisted Laparoscopic Prostatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
November 9, 2017 (Actual)
Primary Completion Date
November 7, 2018 (Actual)
Study Completion Date
November 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Benaroya Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Catheter 16 French
Arm Type
Active Comparator
Arm Description
16 French urinary catheter
Arm Title
Catheter 20 French
Arm Type
Active Comparator
Arm Description
20 French urinary catheter
Intervention Type
Device
Intervention Name(s)
16 French urinary catheter
Intervention Description
16 French urinary catheter
Intervention Type
Device
Intervention Name(s)
20 French urinary catheter
Intervention Description
20 French urinary catheter
Primary Outcome Measure Information:
Title
Catheter Related Pain: Visual Analog Score Rating
Description
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
Secondary Outcome Measure Information:
Title
Urinary Symptoms
Description
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
Title
Quality of Life Score
Description
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
Title
Urinary Symptoms
Description
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
Title
Quality of Life Score
Description
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
Title
Opioid Use
Description
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
Title
Home Opioid Use in Standard Morphine Equivalency
Description
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
Title
Number of Incontinence Pads Used
Description
Patient reported number of incontinence pads used per day. The lower the number the better the outcome.
Time Frame
week 6
Title
Patient Reported Number of Pads Used Per Day.
Description
Patient reported number of incontinence pads used per day. The lower the number the better the outcome.
Time Frame
Week 12
Title
Number of Participants Experiencing Bladder Neck Contracture
Description
Number of incidence of participants experiencing bladder neck contracture.
Time Frame
week 12
Title
Number of Participants Experiencing Bladder Neck Contracture
Description
Number of Incidence of participants experiencing bladder neck contracture.
Time Frame
1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Corman, MD
Organizational Affiliation
Virginia Mason Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Mason Medical center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs