Impact of Catheter Size on Peri-Operative Pain After Robotic Assisted Laparoscopic Prostatectomy
1 other identifier
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable prostate-cancer
Started Nov 2017
Shorter than P25 for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 7, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 7, 2018
CompletedFirst Submitted
Initial submission to the registry
September 11, 2019
CompletedFirst Posted
Study publicly available on registry
September 23, 2019
CompletedResults Posted
Study results publicly available
December 26, 2019
CompletedDecember 26, 2019
December 1, 2019
12 months
September 11, 2019
November 13, 2019
December 10, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Urinary Symptoms
week 6
Quality of Life Score
Week 6
Urinary Symptoms
week 12
Quality of Life Score
Week 12
Opioid Use
after discharge until post-op day 7
- +5 more secondary outcomes
Study Arms (2)
Catheter 16 French
ACTIVE COMPARATOR16 French urinary catheter
Catheter 20 French
ACTIVE COMPARATOR20 French urinary catheter
Interventions
Eligibility Criteria
You may qualify if:
- Identified as candidate for robotic assisted laparoscopic prostatectomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Virginia Mason Medical center
Seattle, Washington, 98101, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Andrew Stamm
- Organization
- Benaroya Research Institute at Virginia Mason
Study Officials
- PRINCIPAL INVESTIGATOR
John Corman, MD
Virginia Mason Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2019
First Posted
September 23, 2019
Study Start
November 9, 2017
Primary Completion
November 7, 2018
Study Completion
November 7, 2018
Last Updated
December 26, 2019
Results First Posted
December 26, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share