A Randomized Controlled Trial on the Effect of Retrograde Partial Bladder Fill on Time to Discharge and Overall Medical Staff Satisfaction

This study is a randomized controlled trial on the effect of retrograde partial bladder fill on time to discharge in patients who have had urological surgery for BPH, and whether it affects overall medical staff satisfaction.

Study Overview

• Status: Completed
• Conditions: Retrograde Bladder Fill
• Intervention / Treatment: Procedure: retrograde bladder filling with 0.9% normal saline 250cc prior to removal of foley catheter

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Any male patient between ages 20-80 with foley catheter indwelled after urological surgery performed at our institution

Exclusion Criteria:

• Any patient that does not remove foley catheter at discharge

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bladder fill; Retrograde bladder filling of 250cc of 0.9% normal saline for irrigation prior to removal of foley catheter	Procedure: retrograde bladder filling with 0.9% normal saline 250cc prior to removal of foley catheter; 0.9% NS 250cc was introduced before foley catheter removed for discharge
No Intervention: No bladder Fill; no filling prior to removal of foley catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to void	time from foley catheter removal to actual initial voiding	1day
Time to discharge	time from foley catheter removal to actual discharge	1day
Medical staff satisfaction	Medical staff satisfaction discomfort/satisfaction with overall process based on a Likert scale (5)	1year
Patient satisfaction	patient discomfort/satisfaction with overall process based on a Likert scale (5)	1day

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Hakmin Lee, M.D., Ph.D, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: March 12, 2020
• First Submitted That Met QC Criteria: March 12, 2020
• First Posted (Actual): March 16, 2020

Study Record Updates

• Last Update Posted (Actual): March 16, 2020
• Last Update Submitted That Met QC Criteria: March 12, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: B-1806-474-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No