Retrograde Bladder FillNCT04309032

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

A study testing retrograde bladder filling with 0.9% normal saline 250cc prior to removal of foley catheter in people with Retrograde Bladder Fill, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 20 to 80 years, men onlyHealthy volunteers can take part
Conditions the study is for: Retrograde Bladder Fill
What is being tested?: retrograde bladder filling with 0.9% normal saline 250cc prior to removal of foley catheter
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 1 siteSouth Korea
Study dates: 1 Nov 2018to 1 Oct 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 80 years
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

Any patient that does not remove foley catheter at discharge

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620

Other trials in South Korea

About this study

Conditions: Retrograde Bladder Fill
Being tested: retrograde bladder filling with 0.9% normal saline 250cc prior to removal of foley catheter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

retrograde bladder filling with 0.9% normal saline 250cc prior to removal of foley catheterProcedure or surgery
0.9% NS 250cc was introduced before foley catheter removed for discharge

Study groups in NCT04309032
Study group	Role	What they receive
Bladder fill	Experimental	Retrograde bladder filling of 250cc of 0.9% normal saline for irrigation prior to removal of foley catheter Receives: Procedure: retrograde bladder filling with 0.9% normal saline 250cc prior to removal of foley catheter
No bladder Fill	No intervention	no filling prior to removal of foley catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 20181 Oct 2019

First posted16 Mar 2020
Study start1 Nov 2018
Primary completion1 Oct 2019
Study completion1 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Retrograde Bladder FillStudies of the same condition, open and under way.
More trials run by Seoul National University HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04309032
Sponsor's protocol ID: B-1806-474-004
Status last verified: Mar 2020
First submitted: 12 Mar 2020
Last updated: 16 Mar 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Trial on the Effect of Retrograde Partial Bladder Fill on Time to Discharge and Overall Medical Staff Satisfaction
ClinicalTrials.gov ID: NCT04309032
Acronym / sponsor ID: B-1806-474-004
Conditions: Retrograde Bladder Fill
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Seoul National University HospitalUniversity, hospital or other
Study start: 1 Nov 2018 (actual)
Primary completion: 1 Oct 2019 (actual)
Study completion: 1 Oct 2019 (actual)
First posted: 16 Mar 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Bladder fill	Experimental	Procedure: retrograde bladder filling with 0.9% normal saline 250cc prior to removal of foley catheterRetrograde bladder filling of 250cc of 0.9% normal saline for irrigation prior to removal of foley catheter
No bladder Fill	No intervention	–no filling prior to removal of foley catheter

Who may qualify

Ages: 20 to 80 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

Any patient that does not remove foley catheter at discharge

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
retrograde bladder filling with 0.9% normal saline 250cc prior to removal of foley catheter0.9% NS 250cc was introduced before foley catheter removed for discharge	Procedure or surgery	Bladder fill

Primary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hakmin Lee, M.D., Ph.D principal investigator

Seoul National University Bundang Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to void (time frame: 1day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04309032.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2020; AzTrials last refreshed its copy on 30 Oct 2026.