Bladder Filling for Faster Patient Discharge

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Tennessee

Disqualifiers: Non-laparoscopic surgery, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The investigators hypothesize that backfilling the bladder postoperatively will reduce time to spontaneous void and subsequent discharge from the post-anesthesia care unit.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Backfill, Bladder Backfilling, Postoperative Bladder Filling for faster patient discharge?

Research shows that backfilling the bladder after surgery can help patients leave the hospital sooner by reducing the time it takes for them to urinate for the first time after surgery. This method has been found to shorten the stay in the recovery area and decrease the need for a catheter (a tube used to drain urine) after surgery. ^{1 2 3 4 5}

How is the treatment 'Bladder Backfilling' unique for faster patient discharge?

Bladder Backfilling is unique because it involves filling the bladder with fluid immediately after surgery, which can help patients urinate sooner and potentially reduce the time they need to stay in the hospital. This method is different from the standard approach where the bladder fills naturally over time, and it may lead to quicker recovery and discharge. ^{1 2 4 6 7}

Eligibility Criteria

This trial is for patients who have undergone outpatient laparoscopic hysterectomy. Specific eligibility criteria are not provided, so it's assumed that participants should be in stable condition post-surgery and able to undergo the intervention of bladder backfilling.

Inclusion Criteria

I am scheduled for a laparoscopic hysterectomy as an outpatient.

I am a woman aged between 18 and 80.

Exclusion Criteria

I am having an emergency surgery that is not done with a camera.

I am a woman aged between 18 and 80.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Surgery and Immediate Postoperative Care

Participants undergo laparoscopic hysterectomy with or without bladder backfilling and immediate postoperative care

1 day

1 visit (in-person)

Post-anesthesia Care Unit Monitoring

Participants are monitored for time to void and time to discharge from the post-anesthesia care unit

Within 3 days following surgery

Follow-up

Participants are monitored for any postoperative complications and overall recovery

1-2 weeks

Treatment Details

Interventions

• Backfill (Procedure)

Trial Overview The study is testing whether filling the bladder with fluid after surgery (backfill) can help patients urinate on their own faster and get discharged sooner from the post-anesthesia care unit.

Participant Groups

Group I: Backfill Experimental Treatment 1 Intervention

Participants will receive 200 mL of room temperature, sterile normal saline instilled retrograde into the bladder at the completion of the surgery prior to Foley catheter removal and the Foley subsequently removed intraoperatively.

Group II: No bladder filling Active Control 1 Intervention

Participants will have the Foley catheter removed intraoperatively at completion of the procedure.

Who Is Running the Clinical Trial?

University of Tennessee

Lead Sponsor

Trials

202

Recruited

146,000+

Findings from Research

Bladder retrofilling in the operating room after outpatient gynecologic surgery significantly reduces the time to first void by an average of 33.5 minutes and time to discharge by 32.0 minutes, based on a meta-analysis of 1,173 patients across eight studies.

There were no significant differences in postoperative urinary retention or urinary tract infections between the retrofilling and passive filling methods, indicating that retrofilling is a safe option with comparable patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrograde Bladder Filling After Outpatient Gynecologic Surgery: A Systematic Review and Meta-analysis. Thiel, PS., Mathur, S., Zakhari, A., et al.[2021]

In a study of 153 women undergoing outpatient laparoscopic hysterectomy, backfilling the bladder before catheter removal significantly reduced the time to first spontaneous void by about 25 minutes (181.1 minutes vs. 206.0 minutes), indicating a potential benefit in postoperative care.

However, the overall time to discharge was not significantly different between the backfill group and the spontaneous voiding group, suggesting that while bladder backfilling aids in quicker voiding, it does not expedite overall discharge from the hospital.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative Bladder Filling After Outpatient Laparoscopic Hysterectomy and Time to Discharge: A Randomized Controlled Trial. Chao, L., Mansuria, S.[2021]

Retrofilling the bladder with 200 mL of saline after laparoscopic gynecologic surgery significantly reduced the median time to first void (104 minutes) compared to standard care (162 minutes), indicating improved postoperative recovery.

Patients who received retrofilling were discharged from the post-anesthesia care unit faster (155 minutes) than those who had immediate catheter removal (227 minutes), with no urinary tract infections reported in either group, highlighting the safety and efficacy of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrograde Bladder Filling after Laparoscopic Gynecologic Surgery: A Double-blind Randomized Controlled Trial. Zakhari, A., Paek, W., Chan, W., et al.[2021]

The new backfill void trial (VT) protocol performed in the operating room (OR) led to a significant reduction in postoperative care unit (PACU) stay by an average of 23 minutes without increasing the need for postoperative catheterization.

In a study of 225 women undergoing urogynecologic surgery, the OR backfill VT showed similar rates of VT failure compared to the standard VT, indicating that the new protocol is both effective and efficient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Streamlining Postoperative Void Trials: A Study Comparing Standard Backfill Versus Backfill in the Operating Room. Meekins, AR., Amundsen, CL., Weidner, AC.[2021]

In a study of 82 women undergoing total laparoscopic hysterectomy, the autofill void trial resulted in a significantly faster discharge time from recovery compared to the backfill void trial, with median times of 176 minutes versus 218 minutes, respectively.

There was no significant difference in the rate of postoperative urinary retention (POUR) between the two methods, with 16.7% in the autofill group and 27.5% in the backfill group, indicating that both methods are similarly effective in managing urinary retention post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative Urinary Retention Rates after Autofill versus Backfill Void Trial following Total Laparoscopic Hysterectomy: A Randomized Controlled Trial. Farag, S., Padilla, PF., Smith, KA., et al.[2021]

The bladder backfilling technique for trial of void (TOV) after outpatient laparoscopic gynecologic surgery resulted in a significantly shorter time to first spontaneous void compared to standard catheter removal, with an average difference of about 25 minutes.

There were no significant differences in postoperative complications, patient satisfaction, or time to discharge between the bladder backfilling and standard TOV techniques, indicating that while bladder backfilling may speed up the time to void, it does not compromise safety or overall patient experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bladder Backfilling versus Standard Catheter Removal for Trial of Void after Outpatient Laparoscopic Gynecologic Surgery: A Systematic Review and Meta-Analysis. Dong, X., Pan, C., Wang, D., et al.[2022]

The retrograde bladder filling (RF) method significantly reduced the time to void and time to discharge after transurethral prostatectomy (TURP) compared to spontaneous voiding (SV), with times of 67 minutes versus 144 minutes and 168 minutes versus 219 minutes, respectively.

Both RF and SV methods showed comparable rates of immediate postoperative complications and similar satisfaction levels among patients and medical staff, indicating that RF is a safe and effective option for catheter removal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical benefits of retrograde bladder filling method prior to catheter removal after TURP for BPH: A prospective randomized trial. Song, SH., Kim, JH., Kim, JK., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Retrograde Bladder Filling After Outpatient Gynecologic Surgery: A Systematic Review and Meta-analysis. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Postoperative Bladder Filling After Outpatient Laparoscopic Hysterectomy and Time to Discharge: A Randomized Controlled Trial. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Retrograde Bladder Filling after Laparoscopic Gynecologic Surgery: A Double-blind Randomized Controlled Trial. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Streamlining Postoperative Void Trials: A Study Comparing Standard Backfill Versus Backfill in the Operating Room. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Postoperative Urinary Retention Rates after Autofill versus Backfill Void Trial following Total Laparoscopic Hysterectomy: A Randomized Controlled Trial. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Bladder Backfilling versus Standard Catheter Removal for Trial of Void after Outpatient Laparoscopic Gynecologic Surgery: A Systematic Review and Meta-Analysis. [2022]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Clinical benefits of retrograde bladder filling method prior to catheter removal after TURP for BPH: A prospective randomized trial. [2022]