N/A
N=52
Impact of Catheter Size on Peri-Operative Pain After Robotic Assisted Laparoscopic Prostatectomy
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04098809 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Catheter Related Pain: Visual Analog Score Rating — 2.67; 2.67 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 16 French urinary catheter (Device); 20 French urinary catheter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Benaroya Research Institute
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Catheter Related Pain: Visual Analog Score Rating |
2.67; 2.67 | — |
| SECONDARY Urinary Symptoms |
6.52; 7.59 | — |
| SECONDARY Quality of Life Score |
2.24; 2.29 | — |
| SECONDARY Urinary Symptoms |
6.52; 7.59 | — |
| SECONDARY Quality of Life Score |
2.24; 2.29 | — |
| SECONDARY Opioid Use |
5.00; 4.48 | — |
| SECONDARY Home Opioid Use in Standard Morphine Equivalency |
37.50; 33.57 | — |
| SECONDARY Number of Incontinence Pads Used |
2.00; 1.79 | — |
| SECONDARY Patient Reported Number of Pads Used Per Day. |
1.17; 1.13 | — |
| SECONDARY Number of Participants Experiencing Bladder Neck Contracture |
0; 1 | — |
| SECONDARY Number of Participants Experiencing Bladder Neck Contracture |
0; 1 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04098809). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.