NCT04098809

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Benaroya Research Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DEVICE	16 French urinary catheter	16 French urinary catheter
DEVICE	20 French urinary catheter	20 French urinary catheter

Timeline

• Start date: 2017-11-09
• Primary completion: 2018-11-07
• Completion: 2018-11-07
• First posted: 2019-09-23
• Last updated: 2019-12-26
• Results posted: 2019-12-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study